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Ibuprofen 400 mg Tablet, 40-count — NDC 71335-2682-03 package photo

Ibuprofen 400 mg Tablet, 40-count

by Bryant Ranch Prepack · 40 TABLET in 1 BOTTLE (71335-2682-3)
NDC 71335-2682-03
🏷️ FDA NDC (as labeled) 71335-2682-3 billing pads the package segment with a zero
This package
Contains40-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.1334/unit — full pricing hub ↓
Also comes in: 15 tablets 71335-2682-09 20 tablets 71335-2682-01 21 tablets 71335-2682-08 30 tablets 71335-2682-02 60 tablets 71335-2682-04 90 tablets 71335-2682-05 100 tablets 71335-2682-07 120 tablets 71335-2682-06
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 Ibuprofen (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026
Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0646-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-2682-3
Product NDC 71335-2682
11-digit billing NDC 71335268203
RxCUI 197805
UNII WK2XYI10QM
Application # ANDA213794
SPL Set ID d50f829d-071f-4299-9b74-0f28caac7118
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 2020-05-08
Route ORAL
Dosage form TABLET
Substance IBUPROFEN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-2682-3 — 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 → 71335-2682-03. 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 cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid 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 holderAUROBINDO PHARMA LTD
FDA applicationANDA213794 (ANDA)
Labeler code71335
First marketedMay 2020
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

📖 What it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It does a lot more than just kill pain. Ibuprofen is an anti-inflammatory drug, so it relieves pain, reduces swelling and inflammation, and brings down fever. Over-the-counter prod...
  • What's ibuprofen actually used for — is it just a painkiller?
  • Yes, it really does help. Ibuprofen can irritate the stomach lining, so taking it with food or a glass of milk significantly reduces the chance of nausea or stomach upset. You don'...
  • Should I take ibuprofen with food? Does it really matter?
📖 Read our full Ibuprofen guide →
1
Nutrient depletion considerations

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

🧪 Full Ibuprofen 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
ShapeOval
ImprintI4
Size16 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

9 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 $0.1334 $5.34 / 40 tablets
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
Ibuprofen 400 mg 00904-5853-40 Major 500 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 00904-7587-40 Major 500 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 42543-0966-07 Strides 500 tablets $0.039 AB Discontinued —
Ibuprofen 400 mg 49483-0602-01 TIME 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 55111-0682-01 Dr. 100 tablets $0.039 — Availability likely —
Ibuprofen 400 mg 59651-0360-01 Aurobindo 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 60687-0446-01 American 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 62135-0400-12 Chartwell 120 tablets $0.039 — Availability likely —
Ibuprofen 400 mg 64380-0809-06 Strides 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 67877-0319-01 Ascend 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 69367-0394-01 Westminster 100 tablets $0.039 — Availability likely —
Ibuprofen 400 mg 70010-0066-01 Granules 100 tablets $0.039 — Availability likely —
Ibuprofen 400 mg 76282-0712-10 EXELAN 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 69238-1101-05 Amneal 500 tablets $0.048 AB FDA listed —
Ibuprofen 400 mg 71921-0180-01 Florida 100 tablets $0.049 AB FDA listed —
Ibuprofen 400 mg 00615-8309-39 NCS 30 tablets — AB FDA listed —
Ibuprofen 400 mg 11788-0008-00 AiPing 34000 tablets — — Discontinued —
Ibuprofen 400 mg 25000-0121-03 MARKSANS 30 tablets — AB FDA listed —
Ibuprofen 400 mg 43063-0872-06 PD-Rx 6 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-2996-00 A-S 16 tablets — AB Discontinued —
Ibuprofen 400 mg 50090-3007-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-5818-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-5819-00 A-S 16 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-6676-00 A-S 16 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-6677-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-7788-00 A-S 90 tablets — — FDA listed —
Ibuprofen 400 mg 50090-7789-00 A-S 16 tablets — — FDA listed —
Ibu 400 mg 51407-0369-05 Golden 500 tablets — AB FDA listed —
Ibuprofen 400 mg 51407-0839-01 Golden 100 tablets — AB FDA listed —
Ibuprofen 400 mg 51655-0048-26 Northwind 90 tablets — AB FDA listed —
Ibuprofen 400 mg 51655-0759-52 Northwind 30 tablets — AB FDA listed —
Ibuprofen 400 mg 53746-0131-01 Amneal 100 tablets — AB FDA listed —
Ibuprofen 400 mg 53746-0464-01 Amneal 100 tablets — AB FDA listed —
Ibuprofen 400 mg 54348-0835-00 PharmPak, 1 tablet — AB FDA listed —
Ibuprofen 400 mg 55154-1380-00 Cardinal 1 tablet — AB FDA listed —
Ibuprofen 400 mg 62207-0354-42 Granules 50 tablets — AB FDA listed —
Ibuprofen 400 mg 63187-0489-20 Proficient 20 tablets — AB FDA listed —
Ibuprofen 400 mg 63187-0967-15 Proficient 15 tablets — AB FDA listed —
Ibuprofen 400 mg 63629-1468-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 65162-0464-03 Amneal 30 tablets — AB FDA listed —
Ibuprofen 400 mg 67296-2184-02 Redpharm 20 tablets — — FDA listed —
Ibuprofen 400 mg 68071-2939-04 NuCare 4 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-3442-03 NuCare 30 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-3507-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-4952-04 NuCare 40 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-5126-03 NuCare 30 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-5134-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-5228-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 400 mg 68788-4039-01 Preferred 100 tablets — — FDA listed —
Ibuprofen 400 mg 68788-8438-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 400 mg 68788-9110-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 400 mg 69367-0447-01 Westminster 100 tablets — AB FDA listed —
Ibuprofen 400 mg 70518-1051-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 400 mg 70518-2432-01 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 400 mg 70518-3861-00 REMEDYREPACK 30 tablets — AB Discontinued —
Ibuprofen 400 mg 71205-0464-15 Proficient 15 tablets — AB FDA listed —
Ibu 400 mg 71205-0604-15 Proficient 15 tablets — AB FDA listed —
Ibuprofen 400 mg 71335-0690-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 71335-1270-01 Bryant 20 tablets — AB Discontinued —
Ibuprofen 400 mg 71335-1517-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mgthis 71335-2682-03 Bryant 40 tablets — AB FDA listed —
Ibuprofen 400 mg 71610-0916-60 Aphena 90 tablets — — FDA listed —
Ibuprofen 400 mg 71610-0969-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 400 mg 72189-0324-30 Direct 30 tablets — AB FDA listed —
Ibuprofen 400 mg 72189-0564-30 Direct_rx 30 tablets — AB FDA listed —
Ibuprofen 400 mg 72789-0185-20 PD-Rx 20 tablets — AB FDA listed —
Ibuprofen 400 mg 72789-0201-06 PD-Rx 6 tablets — AB FDA listed —
ibuprofen 400 mg 73086-0210-01 SKYA 100 tablets — AB FDA listed —
Ibuprofen 400 mg 75907-0331-94 Dr. 4000 tablets — — FDA listed —
Ibuprofen 400 mg 76420-0575-01 Asclemed 100 tablets — AB FDA listed —
Ibuprofen 400 mg 76420-0846-01 Asclemed 100 tablets — — FDA listed —
Ibuprofen 400 mg 82804-0137-15 Proficient 15 tablets — — FDA listed —
Ibuprofen 400 mg 83209-0464-09 Boswell 9 tablets — AB FDA listed —
Ibuprofen 400 mg 85534-0011-00 HAWAII 30 tablets — AB FDA listed —
Ibuprofen 400 mg 85766-0218-01 Sportpharm 100 tablets — AB FDA listed —
Ibuprofen 400 mg 63629-7676-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 55154-2583-00 Cardinal 10 tablets — AB FDA listed —
Ibuprofen 400 mg 72789-0590-30 PD-Rx 30 tablets — — 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

🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 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 Ibuprofen — the program that covers self-administered drugs. 19 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 Ibuprofen. 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
$12.28M
Claims incl. refills
1.8M
Beneficiaries
1.4M
Spend / beneficiary
$8.95
Spend / claim
$6.72
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 Ibuprofen — the ingredient across all brands.

Top reported reactions

Pain19,495
Fatigue18,755
Nausea18,290
Headache16,566
Arthralgia13,469
Dyspnoea13,139
Vomiting13,046

Age at onset

Neonate657
Infant880
Child2,279
Adolescent1,596
Adult26,531
Elderly8,944

Reporter sex

283,500 reports
Male · 34%
Female · 65%
Unknown · 1%

Serious outcomes

Hospitalization85,488
Death18,734
Life-threatening14,904
Disabling11,119
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 21,295 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
71335-2682-01 20 TABLET in 1 BOTTLE (71335-2682-1) 2025-09-17 Active
71335-2682-02 30 TABLET in 1 BOTTLE (71335-2682-2) 2025-09-17 Active
71335-2682-03 You're viewing this 40 TABLET in 1 BOTTLE (71335-2682-3) 2025-09-17 Active
71335-2682-04 60 TABLET in 1 BOTTLE (71335-2682-4) 2025-09-17 Active
71335-2682-05 90 TABLET in 1 BOTTLE (71335-2682-5) 2025-09-17 Active
71335-2682-06 120 TABLET in 1 BOTTLE (71335-2682-6) 2025-09-17 Active
71335-2682-07 100 TABLET in 1 BOTTLE (71335-2682-7) 2025-09-17 Active
71335-2682-08 21 TABLET in 1 BOTTLE (71335-2682-8) 2025-09-17 Active
71335-2682-09 15 TABLET in 1 BOTTLE (71335-2682-9) 2025-09-17 Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-2682-03?
NDC 71335-2682-03 is a 40-count package — 40 tablet in 1 bottle.
What is the difference between NDC 71335-2682-03 and NDC 71335-2682-09?
Both are Ibuprofen 400 mg Tablet — the drug itself is identical. NDC 71335-2682-03 is the 40-count package, while NDC 71335-2682-09 is the 15 tablets package.
What NDC number is used to bill for this package of Ibuprofen 400 mg Tablet?
Bill NDC 71335-2682-03 — the 11-digit billing format is 71335268203. 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 71335-2682-3, 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: 71335-2682-03, written without dashes as 71335268203. 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 71335-2682-03, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2682) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 8 other package presentations of this same product, including 15 tablets (71335-2682-09), 20 tablets (71335-2682-01), 21 tablets (71335-2682-08). 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 115 words ▾

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 treatment and may increase with duration of use [see Warnings and Precautions ]. Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings ].

Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see WARNINGS ).

🎯 Indications and Usage 96 words ▾

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease Suggested Dosage: 1200 mg to 3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).

Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis. The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level doseresponse relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption).

The availability of three tablet strengths facilitates dosage adjustment. In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose. Dysmenorrhea For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

⛔ Contraindications 72 words ▾

CONTRAINDICATIONS Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS , Anaphylactoid Reactions , and PRECAUTIONS , Preexisting Asthma ).

In the setting of coronary artery bypass graft (CABG) surgery [see Warnings ]

⚠️ Warnings ~3 min read ▾

WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several 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.

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 should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as ibuprofen, increases the risk of serious gastrointestinal (GI) events [ see Warnings ]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG [ see Contraindications ]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of ibuprofen tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ibuprofen tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Hypertension NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen tablets, should be used with caution in patients with hypertension.

Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

Additionally, fluid…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.

Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been established. Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis.

The increases in incidence were slight and still within the ranges reported in the table. Incidence Greater than 1% (but less than 3%) Probable Causal Relationship Precise Incidence Unknown (but less than 1%) Probable Causal Relationship* Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown* *Reactions are classified under "Probable Causal Relationship (PCR)" if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven or more events have been reported but the criteria for PCR have not been met. † Reactions occurring in 3% to 9% of patients treated with ibuprofen.

(Those reactions occurring in less than 3% of the patients are unmarked). GASTROINTESTINAL Nausea†, epigastric pain†, heartburn†, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating and flatulence) Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis CENTRAL NERVOUS SYSTEM Dizziness†, headache, nervousness Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS ) Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri DERMATOLOGIC Rash† (including maculopapular type), pruritus Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens- Johnson syndrome, alopecia Toxic epidermal necrolysis, photoallergic skin reactions SPECIAL SENSES Tinnitus Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS ) Conjunctivitis, diplopia, optic neuritis, cataracts HEMATOLOGIC Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS ) Bleeding episodes (eg epistaxis, menorrhagia) METABOLIC/ENDOCRINE Decreased appetite Gynecomastia, hypoglycemic reaction, acidosis CARDIOVASCULAR Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS ) Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations Arrhythmias (sinus tachycardia, sinus bradycardia) ALLERGIC Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS ) Serum sickness, lupus erythematosus syndrome.

Henoch- Schonlein…

🔄 Drug Interactions 69 words ▾

Preexisting asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and NSAIDs has been reported in such aspirin-sensitive patients, ibuprofen tablets should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

🔄 Drug / Laboratory Test Interactions 47 words ▾

Ophthalmological effects Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen tablets, the drug should be discontinued, and the patient should have an ophthalmologic examination which includes central visual fields and color vision testing.

🤰 Pregnancy ~2 min read ▾

Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. 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 ].

Ibuprofen tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS , Gastrointestinal Effects- Risk of Ulceration, Bleeding and Perforation ).

Serious Skin Reactions, including DRESS Advise patients to stop taking ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [ see Warnings ]. 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 ] . Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and "flu-like" symptoms).

If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS ).

Fetal Toxicity Inform pregnant women to avoid use of ibuprofen tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with ibuprofen tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [ see WARNINGS; Fetal Toxicity , PRECAUTIONS; Pregnancy ] .

🧒 Pediatric Use 43 words ▾

Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of ibuprofen tablets on labor and delivery in pregnant women are unknown.

🧓 Geriatric Use 60 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Approximately 1½ hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen.

Two hours after ingestion the child's condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands.

Blood level of ibuprofen was 102.9 mcg/mL approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely recovered. In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae.

Blood level in one child 90 minutes after ingestion was 700 mcg/mL — about 10 times the peak levels seen in absorption-excretion studies. A 19-year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets have been shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a statistically significant reduction in the milder gastrointestinal side effects (see ADVERSE REACTIONS ).

Ibuprofen tablets may be well tolerated in some patients who have had gastrointestinal side effects with aspirin, but these patients when treated with ibuprofen tablets should be carefully followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study involving 885 patients with rheumatoid arthritis treated for up to one year, there were no reports of gastric ulceration with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the aspirin group (statistically significant p<.001).

Gastroscopic studies at varying doses show an increased tendency toward gastric irritation at higher doses. However, at comparable doses, gastric irritation is approximately half that seen with aspirin. Studies using 51 Cr-tagged red cells indicate that fecal blood loss associated with ibuprofen tablets in doses up to 2400 mg daily did not exceed the normal range, and was significantly less than that seen in aspirin-treated patients.

In clinical studies in patients with rheumatoid arthritis, ibuprofen tablets have been shown to be comparable to indomethacin in controlling the signs and symptoms of disease activity and to be associated with a statistically significant reduction of the milder gastrointestinal (see ADVERSE REACTIONS ) and CNS side effects. Ibuprofen tablets may be used in combination with gold salts and/or corticosteroids. Controlled studies have demonstrated that ibuprofen tablets are a more effective analgesic than propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief of the symptoms of primary dysmenorrhea.

In patients with primary dysmenorrhea, ibuprofen tablets have been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce resting and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia. Pharmacodynamics In a healthy volunteer study, ibuprofen 400 mg given once daily, administered 2 hours prior to immediate-release aspirin (81 mg) for 6 days, showed an interaction with the antiplatelet activity of aspirin as measured by % serum thromboxane B2 (TxB2) inhibition at 24 hours following the day-6 aspirin dose [53%].

An interaction was still observed, but minimized, when ibuprofen 400 mg given once-daily was administered as early as 8 hours prior to the immediate-release aspirin dose [90.7%]. However, there was no interaction with the antiplatelet activity of aspirin when ibuprofen 400 mg, given once daily, was administered 2 hours after (but not concomitantly, 15 min, or 30 min after) the immediate-release aspirin dose [99.2%]. In another study, where immediate-release aspirin 81 mg was administered once daily with ibuprofen 400 mg given three times daily (1, 7, and 13 hours post-aspirin dose) for 10 consecutive days, the mean % serum thromboxane B2 (TxB2) inhibition suggested no interaction with the antiplatelet activity of aspirin [98.3%].

However, there were individual subjects with serum TxB2 inhibition below 95%, with the lowest being 90.2%. When a similarly designed study was conducted with enteric-coated aspirin, where healthy subjects were administered enteric-coated aspirin 81 mg once daily for 6…

📦 How Supplied / Storage and Handling 117 words ▾

HOW SUPPLIED Ibuprofen Tablets USP, 400 mg are white to off-white, film-coated, oval shaped tablets debossed with ‘I4’ on one side and plain on the other side. NDC: 71335-2682-1: 20 Tablets in a BOTTLE NDC: 71335-2682-2: 30 Tablets in a BOTTLE NDC: 71335-2682-3: 40 Tablets in a BOTTLE NDC: 71335-2682-4: 60 Tablets in a BOTTLE NDC: 71335-2682-5: 90 Tablets in a BOTTLE NDC: 71335-2682-6: 120 Tablets in a BOTTLE NDC: 71335-2682-7: 100 Tablets in a BOTTLE NDC: 71335-2682-8: 21 Tablets in a BOTTLE NDC: 71335-2682-9: 15 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid excessive heat 40ºC (104ºF). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 108 words ▾

DESCRIPTION Ibuprofen tablets USP contain the active ingredient ibuprofen, which is (±) - 2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white to off-white, crystalline powder with a melting point of 74 to 77°C and is very soluble in alcohol, in methanol, in acetone and in chloroform, slightly soluble in ethyl acetate, practically insoluble in water. The structural formula is represented below: Ibuprofen tablets USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, stearic acid, talc and titanium dioxide.

💬 Information for Patients 152 words ▾

Hepatic effects Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including ibuprofen tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs.

In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen tablets. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen tablets should be discontinued.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.