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celecoxib 100 mg Capsule, 90-count — NDC 71335-0936-04 package photo

celecoxib 100 mg Capsule, 90-count

by Bryant Ranch Prepack · 90 CAPSULE in 1 BOTTLE (71335-0936-4)
NDC 71335-0936-04
🏷️ FDA NDC (as labeled) 71335-0936-4 billing pads the package segment with a zero
This package
Contains90-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.2958/unit — full pricing hub ↓
Also comes in: 10 capsules 71335-0936-07 14 capsules 71335-0936-06 20 capsules 71335-0936-02 30 capsules 71335-0936-01 60 capsules 71335-0936-03 120 capsules 71335-0936-05
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Celecoxib (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 13, 2025 — Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules (AvKARE) · FDA recall D-0460-2025
Class II · May 9, 2025 — Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule (Alembic Pharmaceuticals Limited) · FDA recall D-0459-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-0936-4
Product NDC 71335-0936
11-digit billing NDC 71335093604
NCPDP billing unit EA — each (per item)
RxCUI 205322, 205323
UNII JCX84Q7J1L
Application # ANDA204590
SPL Set ID ac5c0d72-1bb3-4065-b2f4-5516b0869775
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-03-16
Route ORAL
Dosage form CAPSULE
Substance CELECOXIB
GPI-14 66100525000120
GPI class Celecoxib
GCN Seq No 041285
GCN 42001
HICL code 018979
Ingredient (HICL) Celecoxib
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2L
Therapeutic class — specific (HIC3) Nsaids,Cyclooxygenase-2(Cox-2) Selective Inhibitor
AHFS code 28:08.04.08
AHFS class Cyclooxygenase-2 (Cox-2) Inhibitors
FDB label name CELECOXIB 100 MG CAPSULE
FDB brand name Celecoxib
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-0936-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-0936-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other antineoplastic agents, Coxibs, Dihydropyridine derivatives
How it works Cyclooxygenase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA204590 (ANDA)
Labeler code71335
First marketedMar 2016
Product typeHuman Prescription Drug
Portfolio4,433 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CELECOXIB 100 MG CAPSULE Ingredient Celecoxib
📗 Our plain-language guide HelloPharmacist
  • Celecoxib is used for several different conditions depending on the form you have. The capsules treat arthritis pain (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis),...
  • What conditions is celecoxib actually used for?
  • It depends on which form you have. Regular celecoxib capsules at lower doses can be taken with or without food. At higher doses, taking them with food actually helps your body abso...
  • Should I take celecoxib with food or on an empty stomach?
📖 Read our full Celecoxib guide →
1
Nutrient depletion considerations

Celecoxib may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Celecoxib nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeCapsule
ImprintC5;100mg
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2958 $26.62 / 90 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Celecoxib 100 mg 00591-3983-01 Actavis 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 00904-7550-61 Major 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 11788-0113-01 AiPing 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 16714-0732-01 NorthStar 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 23155-0964-01 Avet 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 27808-0296-01 Cranbury 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 33342-0156-11 Macleods 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 42571-0143-01 Micro 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 42806-0721-01 EPIC 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 50228-0157-01 ScieGen 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 50268-0168-15 AvPAK 50 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 60505-3848-01 Apotex 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 60687-0436-01 American 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 62135-0021-60 Chartwell 60 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 65862-0908-01 Aurobindo 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 68180-0396-01 Lupin 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 69367-0301-01 Westminster 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 75834-0237-01 NIVAGEN 100 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 82009-0068-05 Quallent 500 capsules $0.062 AB Availability likely —
Celecoxib 100 mg 83301-0011-01 Mullan 100 capsules $0.062 AB Availability likely —
celecoxib 100 mg 13668-0441-01 Torrent 100 capsules $0.090 AB FDA listed —
Celebrex 100 mg 58151-0083-01 Viatris 100 capsules $9.542 AB Availability likely —
Celecoxib 100 mg 00615-8572-39 NCS 30 capsules — AB FDA listed —
Celecoxib 100 mg 29300-0158-01 Unichem 100 capsules — — FDA listed —
Celecoxib 100 mg 46708-0268-10 Alembic 100 capsules — AB FDA listed —
Celecoxib 100 mg 50090-6380-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0059-52 Northwind 30 capsules — AB FDA listed —
Celecoxib 100 mg 51655-0436-25 Northwind 60 capsules — AB FDA listed —
celecoxib 100 mg 55700-0613-30 Quality 30 capsules — AB FDA listed —
Celecoxib 100 mg 57582-0212-01 Tianjin 100 capsules — AB FDA listed —
Celecoxib 100 mg 60290-0017-01 Umedica 100 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0649-60 ST. 60 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0995-15 St. 15 capsules — AB FDA listed —
Celecoxib 100 mg 62332-0141-08 Alembic 80 capsules — AB FDA listed —
Celecoxib 100 mg 63187-0301-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 63187-0643-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-4095-03 Preferred 30 capsules — AB FDA listed —
celecoxib 100 mg 68788-7286-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 68788-8206-03 Preferred 30 capsules — AB FDA listed —
Celecoxib 100 mg 69097-0422-02 Cipla 30 capsules — AB FDA listed —
Celecoxib 100 mg 69117-0021-01 Yiling 60 capsules — AB FDA listed —
Celecoxib 100 mg 70247-0007-10 Qingdao 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-3424-00 REMEDYREPACK 30 capsules — AB Discontinued —
Celecoxib 100 mg 70518-3826-00 REMEDYREPACK 90 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4009-00 REMEDYREPACK 100 capsules — AB FDA listed —
Celecoxib 100 mg 70518-4508-00 REMEDYREPACK 60 capsules — AB FDA listed —
Celecoxib 100 mg 71205-0020-30 Proficient 30 capsules — AB FDA listed —
celecoxib 100 mg 71205-0439-30 Proficient 30 capsules — AB FDA listed —
Celecoxib 100 mg 71209-0055-03 Cadila 60 capsules — AB FDA listed —
Celecoxib 100 mg 71335-0292-01 Bryant 30 capsules — AB FDA listed —
celecoxib 100 mgthis 71335-0936-04 Bryant 90 capsules — AB FDA listed —
Celecoxib 100 mg 71335-1804-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2019-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 71335-2222-01 Bryant 30 capsules — AB FDA listed —
Celecoxib 100 mg 72162-2254-05 Bryant 500 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0123-30 Direct 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0662-60 Direct_Rx 60 capsules — AB FDA listed —
Celecoxib 100 mg 72241-0023-03 Modavar 60 capsules — AB FDA listed —
celecoxib 100 mg 76420-0243-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0727-01 Asclemed 1 capsule — AB FDA listed —
Celecoxib 100 mg 76420-0843-00 Asclemed 1000 capsules — AB FDA listed —
Celecoxib 100 mg 77771-0157-01 Radha 100 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0142-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0167-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0321-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 80425-0323-01 Advanced 30 capsules — AB FDA listed —
Celecoxib 100 mg 82804-0151-60 Proficient 60 capsules — AB FDA listed —
Celecoxib 100 mg 85509-1237-01 PHOENIX 120 capsules — AB FDA listed —
celecoxib 100 mg 85534-0014-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 85534-0067-00 HAWAII 30 capsules — AB FDA listed —
Celecoxib 100 mg 55154-0160-00 Cardinal 10 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8031-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 72189-0685-72 Direct_Rx 120 capsules — AB FDA listed —
Celecoxib 100 mg 50090-8036-00 A-S 30 capsules — AB FDA listed —
Celecoxib 100 mg 60760-0942-60 St. 60 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Celecoxib — the program that covers self-administered drugs. 25 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Celecoxib. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$38.36M
Claims incl. refills
1.6M
Beneficiaries
1.1M
Spend / beneficiary
$34.12
Spend / claim
$23.40
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Celecoxib — the ingredient across all brands.

Top reported reactions

Pain12,605
Arthralgia11,261
Fatigue10,100
Nausea9,771
Drug Hypersensitivity7,939
Diarrhoea7,598
Headache7,510

Age at onset

Neonate63
Infant15
Child143
Adolescent146
Adult9,514
Elderly5,530

Reporter sex

130,888 reports
Male · 29%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization40,400
Life-threatening7,448
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 8,494 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-0936-01 30 CAPSULE in 1 BOTTLE (71335-0936-1) 2018-08-29 Active
71335-0936-02 20 CAPSULE in 1 BOTTLE (71335-0936-2) 2018-08-29 Active
71335-0936-03 60 CAPSULE in 1 BOTTLE (71335-0936-3) 2018-08-29 Active
71335-0936-04 You're viewing this 90 CAPSULE in 1 BOTTLE (71335-0936-4) 2018-08-29 Active
71335-0936-05 120 CAPSULE in 1 BOTTLE (71335-0936-5) 2018-08-29 Active
71335-0936-06 14 CAPSULE in 1 BOTTLE (71335-0936-6) 2018-08-29 Active
71335-0936-07 10 CAPSULE in 1 BOTTLE (71335-0936-7) 2018-08-29 Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-0936-04?
NDC 71335-0936-04 is a 90-count package — 90 capsule in 1 bottle.
What is the difference between NDC 71335-0936-04 and NDC 71335-0936-07?
Both are celecoxib 100 mg Capsule — the drug itself is identical. NDC 71335-0936-04 is the 90-count package, while NDC 71335-0936-07 is the 10 capsules package.
What NDC number is used to bill for this package of celecoxib 100 mg Capsule?
Bill NDC 71335-0936-04 — the 11-digit billing format is 71335093604. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-0936-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-0936-04, written without dashes as 71335093604. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-0936-04, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0936) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 10 capsules (71335-0936-07), 14 capsules (71335-0936-06), 20 capsules (71335-0936-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. [ see Warnings and Precautions ( 5.1 ) ] • Celecoxib capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ] Gastrointe stinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. [ see Warnings and Precautions ( 5.2 ) ] WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

This risk may occur early in the treatment and may increase with duration of use. ( 5.1 ) • Celecoxib capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 )

🎯 Indications and Usage 191 words ▾

1 INDICATIONS AND USAGE Celecoxib capsules are indicated Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) ( 1.1 ) • Rheumatoid Arthritis (RA) ( 1.2 ) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) • Ankylosing Spondylitis (AS) ( 1.4 ) • Acute Pain (AP) ( 1.5 ) • Primary Dysmenorrhea (PD) ( 1.6 )

1.1Osteoarthritis For the management of the signs and symptoms of OA [ see Clinical Studies ( 14.1 ) ]

1.2Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see Clinical Studies ( 14.2 ) ]

1.3Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies ( 14.3 ) ]

1.4Ankylosing Spondylitis For the management of the signs and symptoms of AS [ see Clinical Studies ( 14.4 ) ]

1.5Acute Pain For the management of acute pain in adults [ see Clinical Studies ( 14.5 ) ]

1.6Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies ( 14.5 ) ]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1 ) • OA: 200 mg once daily or 100 mg twice daily ( 2.2 , 14.1 ) • RA: 100 mg to 200 mg twice daily ( 2.3 , 14.2 ) • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg ( 2.4 , 14.3 ) • AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit ( 2.5 , 14.4 ) • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day.

On subsequent days, 200 mg twice daily as needed ( 2.6 , 14.5 ) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). ( 2.7 , 8.6 , 12.3 ) Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers, ( 2.7, 8.8 , 12.3 ).

2.1General Dosing Instructions Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. These doses can be given without regard to timing of meals.

2.2Osteoarthritis For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.

2.3Rheumatoid Arthritis For RA, the dosage is 100 mg to 200 mg twice daily.

2.4Juvenile Rheumatoid Arthritis For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsules can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2° C to 8° C/ 35° F to 45° F).

2.5Ankylosing Spondylitis For AS, the dosage of celecoxib capsules are 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

2.6Management of Acute Pain and Treatment of Primary Dysmenorrhea For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

2.7Special Populations Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 ) ]. Poor Metabolizers of CYP2C9 Substrates In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin), initiate treatment with half of the lowest recommended dose.

In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments [ see Use in Specific populations ( 8.8 ) and Clinical Pharmacology ( 12.5 ) ].

💊 Dosage Forms and Strengths 133 words ▾

3 DOSAGE FORMS AND STRENGTHS Celecoxib capsules: 50 mg white opaque cap, white opaque body with 'C4' imprinted on the red band on the cap and '50mg' imprinted on the red band on the body. 100 mg white opaque cap, white opaque body with 'C5' imprinted on the blue band on the cap and '100mg' imprinted on the blue band on the body. 200 mg white opaque cap, white opaque body with 'C6' imprinted on the yellow band on the cap and '200mg' imprinted on the yellow band on the body.

400 mg white opaque cap, white opaque body with 'C7' imprinted on the green band on the cap and '400mg' imprinted on the green band on the body. Celecoxib capsules: 50 mg, 100 mg, 200 mg and 400 mg ( 3 )

⛔ Contraindications 149 words ▾

4 CONTRAINDICATIONS • Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ]. • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ]. • In the setting of CABG surgery [ see Warnings and Precautions ( 5.1 ) ]. • In patients who have demonstrated allergic-type reactions to sulfonamides. • Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides ( 4 ) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) • In the setting of CABG surgery ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) • Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) • Heart Failure and Edema : Avoid use of celecoxib capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) • Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Avoid use of celecoxib capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) • Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) • Exacerbation of Asthma Related to Aspirin Sensitivity : celecoxib capsules are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.8 ) • Serious Skin Reactions : Discontinue celecoxib capsules at first appearance of skin rash or other signs of hypersensitivity ( 5.9 ) • Premature Closure of Fetal Ductus Arteriosus : Avoid use in pregnant women starting at 30 weeks of gestation ( 5.10 , 8.1 ) • Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.11 , 7 )

5.1Cardiovascular Thrombotic Events Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

In the APC (Adenoma Prevention with Celecoxib) trial, there was about a threefold increased risk of the composite endpoint of cardiovascular death, MI, or stroke for the celecoxib capsules 400 mg twice daily and celecoxib capsules 200 mg twice daily treatment arms compared to placebo. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [see Clinical Studies ( 14.7 )]. A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs.

Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non-selective NSAIDs naproxen and ibuprofen. Celecoxib 100 mg twice daily was non-inferior to naproxen 375 to 500 mg twice daily and ibuprofen 600 to 800 mg three times daily for the composite endpoint of the Antiplatelet Trialists' Collaboration (APTC), which consists of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and nonfatal stroke [see Clinical Studies ( 14.6 )].

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients sh…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] • GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] • Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] • Hypertension [ see Warnings and Precautions ( 5.4 ) ] • Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] • Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] • Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] • Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] • Hematologic Toxicity [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions in arthritis trials (>2% and >placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Of the celecoxib capsules-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain.

More than 8,500 patients received a total daily dose of celecoxib capsules of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received celecoxib capsules at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more. Pre-marketing Controlled Arthritis Trials Table 1 lists all adverse events, regardless of causality, occurring in ≥2% of patients receiving celecoxib capsules from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence. Table 1: Adverse Events Occurring in ≥2% of Celecoxib Patients from Pre-marketing Controlled Arthritis Trials CBX N=4146 Placebo N=1864 NAP N=1366 DCF N=387 IBU N=345 Gastrointestinal Abdominal Pain Diarrhea Dyspepsia Flatulence Nausea 4.1% 5.6% 8.8% 2.2% 3.5% 2.8% 3.8% 6.2% 1.0% 4.2% 7.7% 5.3% 12.2% 3.6% 6.0% 9.0% 9.3% 10.9% 4.1% 3.4% 9.0% 5.8% 12.8% 3.5% 6.7% Body as a whole Back Pain Peripheral Edema Injury-Accidental 2.8% 2.1% 2.9% 3.6% 1.1% 2.3% 2.2% 2.1% 3.0% 2.6% 1.0% 2.6% 0.9% 3.5% 3.2% Central, Peripheral Nervous system Dizziness Headache 2.0% 15.8% 1.7% 20.2% 2.6% 14.5% 1.3% 15.5% 2.3% 15.4% Psychiatric Insomnia 2.3% 2.3% 2.9% 1.3% 1.4% Respiratory Pharyngitis Rhinitis Sinusitis Upper Respiratory Infection 2.3% 2.0% 5.0% 8.1% 1.1% 1.3% 4.3% 6.7% 1.7% 2.4% 4.0% 9.9% 1.6% 2.3% 5.4% 9.8% 2.6% 0.6% 5.8% 9.9% Skin Rash 2.2% 2.1% 2.1% 1.3% 1.2% CBX = Celecoxib 100 mg to 200 mg twice daily or 200 mg once daily; NAP = Naproxen 500 mg twice daily; DCF = Diclofenac 75 mg twice daily; IBU = Ibuprofen 800 mg three times daily.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving celecoxib capsules and 6.1% for patients receiving placebo. Among the most common reasons…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with celecoxib. Table 3: Clinically Significant Drug Interactions with Celecoxib Drugs That Interfere with Hemostasis Clinical Impact: · Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of Celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. · Serotonin release by platelets plays an important role in hemostasis.

Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of celecoxib capsules with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [ see Warnings and Precautions ( 5.11 ) ]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone.

In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [ see Warnings and Precautions ( 5.2 ) ]. In two studies in healthy volunteers, and in patients with osteoarthritis and established heart disease respectively, celecoxib (200 mg to 400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100 mg to 325 mg). Intervention: Concomitant use of celecoxib capsules and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions ( 5.11 ) ].

Celecoxib capsules are not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: · NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers (including propranolol). · In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. Intervention: · During concomitant use of celecoxib capsules and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. · During concomitant use of celecoxib capsules and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see Warnings and Precautions ( 5.6 ) ] . · When these drugs are administered concomitantly, patients should be adequately hydrated.

Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

Intervention: During concomitant use of celecoxib capsules with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [ see Warnings and Precautions ( 5.6 ) ]. Digoxin Clinical Impact: The concomitant use of Celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of celecoxib capsules and digoxin, monitor serum digoxin levels.

Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance . The mean minimum lithium…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy : Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation ( 5.10 , 8.1 ) • Infertility : NSAIDs are associated with reversible infertility. Consider withdrawal of celecoxib capsules in women who have difficulties conceiving ( 8.3 )

8.1Pregnancy Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Avoid use of NSAIDs, including celecoxib capsules, in pregnant women starting at 30 weeks of gestation. There are no adequate and well-controlled studies of celecoxib capsules in pregnant women. Data from observational studies regarding potential embryo-fetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily. In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD [see Data].

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post-implantation loss. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. Clinical Considerations Labor or Delivery There are no studies on the effects of celecoxib capsules during labor or delivery.

In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib capsules. Animal data Celecoxib at oral doses ≥150 mg/kg/day (approximately 2 times the human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis.

A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6 times human exposure based on the AUC 0-24 at 200 mg twice daily for RA) throughout organogenesis. In rats, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses at oral doses ≥50 mg/kg/day (approximately 6 times human exposure based on the AUC 0-24 at 200 mg twice daily for RA). Celecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC 0-24 at 200 mg twice daily).

The effects of celecoxib capsules on labor and delivery in pregnant women are unknown.

8.2Lactation Risk Summary Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of celecoxib in breast milk. The calculated average daily infant…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Avoid use of NSAIDs, including celecoxib capsules, in pregnant women starting at 30 weeks of gestation. There are no adequate and well-controlled studies of celecoxib capsules in pregnant women. Data from observational studies regarding potential embryo-fetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

In animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately 6 times the maximum recommended human dose (MRHD) of 200 mg twice daily. In addition, structural abnormalities (e.g., septal defects, ribs fused, sternebrae fused and sternebrae misshapen) were observed in rabbits given daily oral doses of celecoxib during the period of organogenesis at approximately 2 times the MRHD [see Data].

Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as celecoxib, resulted in increased pre- and post-implantation loss. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. Clinical Considerations Labor or Delivery There are no studies on the effects of celecoxib capsules during labor or delivery.

In animal studies, NSAIDs, including celecoxib, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data The available data do not establish the presence or absence of developmental toxicity related to the use of celecoxib capsules. Animal data Celecoxib at oral doses ≥150 mg/kg/day (approximately 2 times the human exposure at 200 mg twice daily as measured by AUC 0-24 ), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis.

A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥30 mg/kg/day (approximately 6 times human exposure based on the AUC 0-24 at 200 mg twice daily for RA) throughout organogenesis. In rats, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses at oral doses ≥50 mg/kg/day (approximately 6 times human exposure based on the AUC 0-24 at 200 mg twice daily for RA). Celecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC 0-24 at 200 mg twice daily).

The effects of celecoxib capsules on labor and delivery in pregnant women are unknown.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Celecoxib capsules are approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children. The long-term cardiovascular toxicity in children exposed to celecoxib capsules has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to celecoxib capsules or other COX-2 selective and non-selective NSAIDs [ see Boxed Warning, Warnings and Precautions ( 5.12 ), and Clinical Studies ( 14.3 )].

The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension. Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features. Patients with systemic onset JRA (without active systemic features) appear to be at risk for the development of abnormal coagulation laboratory tests.

In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT). When NSAIDs including celecoxib are used in patients with systemic onset JRA, monitor patients for signs and symptoms of abnormal clotting or bleeding, due to the risk of disseminated intravascular coagulation. Patients with systemic onset JRA should be monitored for the development of abnormal coagulation tests [ see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.12 ), Adverse Reactions ( 6.3 ), Animal Toxicology ( 13.2 ), Clinical Studies ( 14.3 ) ].

Alternative therapies for treatment of JRA should be considered in pediatric patients identified to be CYP2C9 poor metabolizers [ see Poor Metabolizers of CYP2C9 substrates ( 8.8 ) ].

🧓 Geriatric Use 190 words ▾

8.5Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3, 5.6 , 5.13 ) ]. Of the total number of patients who received celecoxib capsules in pre-approval clinical trials, more than 3,300 were 65-74 years of age, while approximately 1,300 additional patients were 75 years and over.

No substantial differences in effectiveness were observed between these subjects and younger subjects. In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers. However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous post-marketing reports of fatal GI events and acute renal failure in the elderly than in younger patients [ see Warnings and Precautions ( 5.4 , 5.6 ) ].

🆘 Overdosage 212 words ▾

10 OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occured, but were rare [ see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.6 ) ].

No overdoses of celecoxib capsules were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose.

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).

Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib capsules are believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro.

Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

12.2Pharmacodynamics Platelets In clinical trials using normal volunteers, celecoxib capsules at single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days duration (higher than recommended therapeutic doses) had no effect on reduction of platelet aggregation or increase in bleeding time. Because of its lack of platelet effects, celecoxib capsules are not a substitute for aspirin for cardiovascular prophylaxis. It is not known if there are any effects of celecoxib capsules on platelets that may contribute to the increased risk of serious cardiovascular thrombotic adverse events associated with the use of celecoxib capsules.

Fluid Retention Inhibition of PGE2 synthesis may lead to sodium and water retention through increased reabsorption in the renal medullary thick ascending loop of Henle and perhaps other segments of the distal nephron. In the collecting ducts, PGE2 appears to inhibit water reabsorption by counteracting the action of antidiuretic hormone.

12.3Pharmacokinetics Celecoxib exhibits dose-proportional increase in exposure after oral administration up to 200 mg twice daily and less than proportional increase at higher doses. It has extensive distribution and high protein binding. It is primarily metabolized by CYP2C9 with a half-life of approximately 11 hours.

Absorption Peak plasma levels of celecoxib occur approximately 3 hours after an oral dose. Under fasting conditions, both peak plasma levels (C max ) and area under the curve (AUC) are roughly dose-proportional up to 200 mg twice daily; at higher doses there are less than proportional increases in C max and AUC [see Food Effects]. Absolute bioavailability studies have not been conducted.

With multiple dosing, steady-state conditions are reached on or before Day 5. The pharmacokinetic parameters of celecoxib in a group of healthy subjects are shown in Table 4. Table 4 Summary of Single Dose (200 mg) Disposition Kinetics of Celecoxib in Healthy Subjects 1 Mean (%CV) PK Parameters Values C max , ng/mL T max , hr Effective t 1/2 , hr V ss /F, L CL/F, L/hr 705(38) 2.8(37) 11.2(31) 429(34) 27.7(28) 1 Subjects under fasting conditions (n=36, 19-52 yrs.) Food Effects When celecoxib capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%.

Under fasting conditions, at doses above 200 mg, there is less than a proportional increase in C max and AUC, which is thought to be due to the low solubility of the drug in aqueous media. Coadministration of celecoxib capsules with an aluminum- and magnesium-containing antacids resulted in a reduction in plasma celecoxib concentrations with a decrease of 37% in Cmax and 10% in AUC. Celecoxib capsules, at doses up to 200 mg twice daily, can be administered without regard to timing of meals.

Higher doses (400 mg twice daily) should be administered with food to improve absorption. In healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in C max , T max or t 1/2 after administration of capsule contents on applesauce [ see Dosage and Admini…

🧬 Mechanism of Action 97 words ▾

12.1Mechanism of Action Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib capsules are believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro.

Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Celecoxib Capsules 200 mg Size '2', White opaque cap, white opaque body with 'C6' imprinted on the yellow band on the cap and '200mg' imprinted on the yellow band on the body and are available as follows: NDC 71335-0868-1: 30 CAPSULE in a BOTTLE NDC 71335-0868-2: 60 CAPSULE in a BOTTLE NDC 71335-0868-3: 90 CAPSULE in a BOTTLE NDC 71335-0868-4: 14 CAPSULE in a BOTTLE NDC 71335-0868-5: 20 CAPSULE in a BOTTLE NDC 71335-0868-6: 10 CAPSULE in a BOTTLE NDC 71335-0868-7: 180 CAPSULE in a BOTTLE NDC 71335-0868-8: 28 CAPSULE in a BOTTLE NDC 71335-0868-9: 56 CAPSULE in a BOTTLE NDC 71335-0868-0: 15 CAPSULE in a BOTTLE Celecoxib Capsules 400 mg Size '0 elongated', White opaque cap, white opaque body with 'C7' imprinted on the green band on the cap and '400mg' imprinted on the green band on the body and are available as follows: NDC 71335-0936-1: 30 CAPSULE in a BOTTLE NDC 71335-0936-2: 20 CAPSULE in a BOTTLE NDC 71335-0936-3: 60 CAPSULE in a BOTTLE NDC 71335-0936-4: 90 CAPSULE in a BOTTLE NDC 71335-0936-5: 120 CAPSULE in a BOTTLE NDC 71335-0936-6: 14 CAPSULE in a BOTTLE NDC 71335-0936-7: 10 CAPSULE in a BOTTLE Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description ~1 min read ▾

11 DESCRIPTION Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38.

Its molecular formula is C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, hydroxypropyl cellulose, crospovidone and titanium dioxide.

The imprinting ink of capsule shell of the 50 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red#40 Aluminum Lake- E129. The imprinting ink of capsule shell of the 100 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and FD&C Blue#2 Aluminum Lake-E132. The imprinting ink of capsule shell of the 200 mg capsule contains the following inactive ingredients: shellac, propylene glycol, strong ammonia solution and yellow iron oxide.

The imprinting ink of capsule shell of the 400 mg capsule contains the following inactive ingredients: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide, FD&C Blue#1 Aluminum Lake- E133 and FD&C Yellow#5 Aluminum Lake-E102. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with celecoxib capsules and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions ( 5.1 ) ].

Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions ( 5.2 ) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea jaundice, right upper quadrant tenderness, and “flu-like” symptoms).

If these occur, instruct patients to stop celecoxib capsules and seek immediate medical therapy [ see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.6 ) ]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions ( 5.5 ) ]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).

Instruct patients to seek immediate emergency help if these occur [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.7 ) ]. Serious Skin Reactions Advise patients to stop celecoxib capsules immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [ see Warnings and Precautions ( 5.9 ) ]. Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including celecoxib capsules, may be associated with a reversible delay in ovulation [ see Use in Specific Populations ( 8.3 ) ].

Fetal Toxicity Inform pregnant women to avoid use of celecoxib capsules and other NSAIDs starting at 30 weeks of gestation because of the risk of the premature closing of the fetal ductus arteriosus [ see Warnings and Precautions ( 5.10 ) and Use in Specific Populations ( 8.1 ) ]. Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of celecoxib capsules with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7 ) ].

Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with celecoxib capsules until they talk to their healthcare provider [ see Drug Interactions ( 7 ) ]. Manufactured for : Macleods Pharma USA, Inc.

Plainsboro, NJ 08536 Manufactured by : Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA Revision Date: June 2019

💬 Medication Guide ~3 min read ▾

. Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death.

This risk may happen early in treatment and may increase: o with increasing doses of NSAIDs o with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: o anytime during use o without warning symptoms o that may cause death • The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs” o increasing doses of NSAIDs o older age o longer use of NSAIDs o poor health o smoking o advanced liver disease o drinking alcohol o bleeding problems • NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery.

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems • have high blood pressure • have asthma • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy • are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? • new or worse high blood pressure • heart failure • liver problems including liver failure • kidney problems including kidney failure • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: • shortness of breath or trouble breathing • slurred speech • chest pain • swelling of the face or throat • weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: • nausea • vomit blood • more tired or weaker than usual • there is blood in your bowel movement or it is black and sticky like tar • diarrhea • unusual weight gain • itching • skin rash or blisters with fever • your skin or eyes look yellow • swelling of the arms, legs, hands and feet • indigestion or stomach pain • flu-like symptoms If you take too much of your NSAID, call your healthcare provider or get medical help right away.

T…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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