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Ibuprofen 400 mg Tablet, 180-count — NDC 71610-0969-80 package photo

Ibuprofen 400 mg Tablet, 180-count

by Aphena Pharma Solutions - Tennessee, LLC · 180 TABLET in 1 BOTTLE (71610-969-80)
NDC 71610-0969-80
🏷️ FDA NDC (as labeled) 71610-969-80 billing pads the product segment with a zero
This package
Contains180-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1334/unit — full pricing hub ↓
Also comes in: 90 tablets 71610-0969-60 270 tablets 71610-0969-92
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) 71610-969-80
Product NDC 71610-969
11-digit billing NDC 71610096980
NCPDP billing unit EA — each (per item)
RxCUI 197805
UNII WK2XYI10QM
Application # ANDA075682
SPL Set ID 4522cb9e-4999-c455-e063-6294a90a294f
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 2025-09-26
Route ORAL
Dosage form TABLET
Substance IBUPROFEN
GCN Seq No 008348
GCN 35741
HICL code 003723
Ingredient (HICL) Ibuprofen
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2B
Therapeutic class — specific (HIC3) Nsaids, Cyclooxygenase Inhibitor Type Analgesics
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name IBUPROFEN 400 MG TABLET
FDB brand name Ibuprofen
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 71610-969-80 — a 5-3-2 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 product segment → 71610-0969-80. 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderDR REDDYS LABORATORIES INC
FDA applicationANDA075682 (ANDA)
Labeler code71610
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio794 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 IBUPROFEN 400 MG TABLET Ingredient Ibuprofen
📖 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
Imprint4I
Size8 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 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.

10 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 $24.01 / 180 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 Availability likely —
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 mg 71335-2682-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 71610-0916-60 Aphena 90 tablets — — FDA listed —
Ibuprofen 400 mgthis 71610-0969-80 Aphena 180 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 —
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

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year 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
71610-0969-60 90 TABLET in 1 BOTTLE (71610-969-60) 2025-12-03 Active
71610-0969-80 You're viewing this 180 TABLET in 1 BOTTLE (71610-969-80) 2025-12-03 Active
71610-0969-92 270 TABLET in 1 BOTTLE (71610-969-92) 2025-12-03 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0969-80?
NDC 71610-0969-80 is a 180-count package — 180 tablet in 1 bottle.
What is the difference between NDC 71610-0969-80 and NDC 71610-0969-60?
Both are Ibuprofen 400 mg Tablet — the drug itself is identical. NDC 71610-0969-80 is the 180-count package, while NDC 71610-0969-60 is the 90 tablets package.
What NDC number is used to bill for this package of Ibuprofen 400 mg Tablet?
Bill NDC 71610-0969-80 — the 11-digit billing format is 71610096980. 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 71610-969-80, 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: 71610-0969-80, written without dashes as 71610096980. 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 71610-0969-80, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0969) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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 Aphena Pharma Solutions - Tennessee, LLC. 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 2 other package presentations of this same product, including 90 tablets (71610-0969-60), 270 tablets (71610-0969-92). 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?
Aphena Pharma Solutions - Tennessee, LLC 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 and Cautions ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 112 words ▾

BOXED WARNING 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 gastrointestinaladverse events including bleeding, ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinalevents.

(See WARNINGS ).

🎯 Indications and Usage 93 words ▾

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual 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 tabletsand other treatment options before deciding to use Ibuprofen tablets. Usethe lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with Ibuprofen tablets, thedose and frequency should be adjusted to suit an individual patient’sneeds.Do not exceed 3200 mg total daily dose.

If gastrointestinal complaintsoccur, administer Ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease: Suggested Dosage: 1,200 mg to 3,200 mg daily (400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better responseto 3200 mg daily, as compared with 2,400 mg, although in well-controlledclinical trials patients on 3,200 mg did not show a better meanresponse in terms of efficacy.

Therefore, when treating patients with 3,200 mg/day, the physician should observe sufficient increased clinicalbenefits to offset potential increased risk.The dose should be tailored to each patient, and may be loweredor raised depending on the severity of symptoms either at time of initiatingdrug therapy or as the patient responds or fails to respond.In general, patients with rheumatoid arthritis seem to require higherdoses of Ibuprofen tablets than do patients with osteoarthritis. The smallest dose of Ibuprofen tablets that yields acceptable controlshould be employed.

A linear blood level dose-response relationshipexists 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 isobserved by two weeks. After a satisfactory response has beenachieved, the patient’s dose should be reviewed and adjusted asrequired.

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

⛔ Contraindications 70 words ▾

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

Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery(see WARNINGS ).

⚠️ Warnings and Cautions 75 words ▾

Fetal Toxicity Inform pregnant women to avoid use of Ibuprofen 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 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].

⚠️ 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 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 to follow-up. Avoid the use of Ibuprofen in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Ibuprofen is 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 hypertensionor worsening of preexisting hypertension, either of which maycontribute to the increased incidence of CV events. Patients takingthiazides or loop diuretics may have impaired response to these therapieswhen taking NSAIDs. NSAIDs, including Ibuprofen tablets, should beused with caution in patients with hypertension.

Blood pressure (BP)should be monitored closely during the initiation of NSAID treatmentand throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trails 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 retention and edema have been obs…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In controlled clinical trials thepercentage of patients reporting one or more gastrointestinal complaintsranged from 4% to 16%. In controlled studies when Ibuprofen tablets were compared toaspirin and indomethacin in equally effective doses, the overall incidenceof gastrointestinal complaints was about half that seen in eitherthe aspirin- or indomethacin-treated patients.

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

Still other reactions occurring less frequently than 1 in 100 werereported in controlled clinical trials and from marketing experience.These reactions have been divided into two categories: Column twoof the table lists reactions with therapy with Ibuprofen tablets wherethe probability of a causal relationship exists: for the reactions inColumn three, a causal relationship with Ibuprofen tablets has notbeen established. Reported side effects were higher at doses of 3,200 mg/day thanat doses of 2,400 mg or less per day in clinical trials of patients withrheumatoid arthritis.

The increases in incidence were slight and stillwithin 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** GASTROINTESTINAL Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating or flatulence).

Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, 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, pseudotumor 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, sco-tomata 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, elevate 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 vasculitis, angiodema RENAL Acute renal failure (see PRECAUTIONS ), decreased creatinine clearance, poliuria, azotemia, cystitis, Hematuria Renal papillary necrosis MISCELLANEOUS Dry eyes and mouth, gingival ulcer, rhinitis * Reactions occurring in 3% to 9% of patients treated with ibuprofen. (Those reactions occurring in less than 3% of the patients are unmarked.) ** Reactions are classified under “Probable Causal Relationship (PCR)” if there has been one positive rechallange or if three o…

🔄 Drug Interactions 211 words ▾

Drug Interactions ACE-inhibitors: Reports suggest that NSAIDs may diminish the antihypertensiveeffect of ACE-inhibitors. This interaction should be given considerationin patients taking NSAIDs concomitantly with ACE-inhibitors. Aspirin : Pharmacodynamic studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric­ coated low-dose aspirin.

The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a once­ daily regimen of ibuprofen; however, this finding cannot be extended to enteric-coated low-dose aspirin [see Clinical Pharmacology/Pharmacodynamics ]. Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking low-dose aspirin for cardio protection who require analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics, where appropriate.

When Ibuprofen tablets are administered with aspirin, its protein bindingis reduced, although the clearance of free Ibuprofen tablets is notaltered. The clinical significance of this interaction is not known; however,as with other NSAIDs, concomitant administration of ibuprofenand aspirin is not generally recommended because of the potential forincreased adverse effects.

🤰 Pregnancy ~2 min read ▾

Pregnancy Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs, including Ibuprofen, in pregnant women at about 30 week’s gestation and later. NSAIDs including Ibuprofen, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. Oligohydramnios/Neonatal Renal Impairment: Use of NSAIDs, including Ibuprofen, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation.

In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit Ibuprofen use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Ibuprofen treatment extends beyond 48 hours.

Discontinue Ibuprofen if oligohydramnios occurs and follow up according to clinical practice [see PRECAUTIONS ; Pregnancy]

Ophthalmological effects . Blurred and/or diminished vision, scotomata, and/or changes incolor vision have been reported. If a patient develops such complaintswhile receiving Ibuprofen tablets, the drug should be discontinued, and thepatient should have an ophthalmologic examination which includescentral visual fields and color vision testing.

Pregnancy Risk Summary Use of NSAIDs, including Ibuprofen, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Ibuprofen use between about 20 and 30 weeks of gestation, and avoid Ibuprofen use at about 30 weeks of gestation and later in pregnancy [see WARNINGS; Fetal Toxicity ]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Ibuprofen, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data fromobservational studies regarding other potential embryofetal risks of NSAIDuse in women in the first or second trimesters of pregnancy areinconclusive. Reproductive studies conducted in rats and rabbits have notdemonstrated evidence of developmental abnormalities.

However, animalreproduction studies are not always predictive of human response. Basedon animal data, prostaglandins have been shown to have an importantrole in endometrial vascular permeability, blastocyst implantation, anddecidualization. In animal studies, administration of prostaglandinsynthesis inhibitors such as ibuprofen, resulted in increased pre- and postimplantationloss.

Prostaglandins also have been shown to have animportant role in fetal kidney development. In published animal studies,prostaglandin synthesis inhibitors have been reported to impair kidneydevelopment when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Clinical Conside…

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Approximately 1 1⁄2 hours after the reported ingestion of from 7 to10 Ibuprofen tablets (400 mg), a 19-month old child weighing 12 kgwas 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 fluidswere given; a greenish-yellow fluid was aspirated from the stomachwith no evidence to indicate the presence of ibuprofen.

Two hoursafter ingestion the child’s condition seemed stable; she still respondedonly to painful stimuli and continued to have periods of apnea lastingfrom 5 to 10 seconds. She was admitted to intensive care andsodium bicarbonate was administered as well as infusions of dextroseand normal saline. By four hours post-ingestion she could bearoused easily, sit by herself and respond to spoken commands.Blood level of ibuprofen was 102.9 mcg/mL approximately 8 1⁄2 hoursafter accidental ingestion.

At 12 hours she appeared to be completelyrecovered. In two other reported cases where children (each weighingapproximately 10 kg) accidentally, acutely ingested approximately120 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 aperiod of a few hours complained of dizziness, and nystagmus wasnoted. After hospitalization, parenteral hydration and three days bedrest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied byvomiting or lavage, though little drug will likely be recovered if morethan an hour has elapsed since ingestion. Because the drug is acidicand is excreted in the urine, it is theoretically beneficial to administeralkali and induce diuresis. In addition to supportive measures, the useof oral activated charcoal may help to reduce the absorption andreabsorption of Ibuprofen tablets.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Ibuprofen tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin synthetaseinhibition. In clinical studies in patients with rheumatoid arthritis andosteoarthritis, Ibuprofen tablets have been shown to be comparableto aspirin in controlling pain and inflammation and to be associatedwith a statistically significant reduction in the milder gastrointestinalside effects (see ADVERSE REACTIONS ).

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

Gastroscopic studies at varying doses show an increased tendencytoward gastric irritation at higher doses. However, at comparabledoses, gastric irritation is approximately half that seen with aspirin.Studies using 51Cr-tagged red cells indicate that fecal blood lossassociated with Ibuprofen tablets in doses up to 2,400 mg daily didnot exceed the normal range, and was significantly less than thatseen in aspirin-treated patients. In clinical studies in patients with rheumatoid arthritis, Ibuprofen has been shown to be comparable to indomethacin in controlling thesigns and symptoms of disease activity and to be associated with astatistically significant reduction of the milder gastrointestinal (see ADVERSE REACTIONS ) and CNS side effects.

Ibuprofen may be used in combination with gold salts and/or corticosteroids. Controlled studies have demonstrated that Ibuprofen is a more effective analgesic than propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief ofthe symptoms of primary dysmenorrhea. In patients with primary dysmenorrhea, Ibuprofen has been shown to reduce elevated levels of prostaglandin activity in the menstrualfluid and to reduce resting and active intrauterine pressure, as well asthe frequency of uterine contractions.

The probable mechanism ofaction 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 days and ibuprofen 400 mg three times daily (2, 7 and 12 h post-aspirin dose) for 6…

📦 How Supplied / Storage and Handling 101 words ▾

HOW SUPPLIED Ibuprofen tablets are available in the following strengths, colors and sizes: 400 mg : Oval shaped, white, film-coated tablet debossed "4I" on one side. Bottles of 100 NDC 51407-839-01 Bottles of 500 NDC 51407-839-05 600 mg : Caplet shaped, white, film-coated tablet Debossed "6I" on one side. Bottles of 100 NDC 51407-840-01 Bottles of 500 NDC 51407-840-05 800 mg : Caplet shaped, white, film-coated tablet debossed "8I" on one side.

Bottles of 100 NDC 51407-841-01 Bottles of 500 NDC 51407-841-05 Store at room temperature. Avoid excessive heat 40°C (104°F). Revised: 09/2025 Marketed by: GSMS, Inc.

Camarillo, CA 93012 USA

📋 Description 92 words ▾

DESCRIPTION Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide. strucuture

💬 Information for Patients ~3 min read ▾

Information for Patients Patients should be informed of the following information beforeinitiating therapy with an NSAID and periodically during the course ofongoing therapy. Patients should also be encouraged to read theNSAID 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 mayresult in hospitalization and even death.

Although serious GI tractulcerations and bleeding can occur without warning symptoms,patients should be alert for the signs and symptoms of ulcerationsand bleeding, and should ask for medical advice when observingany indicative signs or symptoms including epigastric pain, dyspepsia,melena, and hematemesis. Patients should be apprised of theimportance of this follow-up (see WARNINGS, Gastrointestinal Effects-Risk of Ulceration , Bleeding and Perforation) . • Ibuprofen tablets, like other NSAIDs, can cause serious skin side effectssuch as exfoliative dermatitis, SJS and TEN, which may result inhospitalization and even death.

Although serious skin reactions mayoccur without warning, patients should be alert for the signs andsymptoms of skin Reaction and blisters, fever, or other signs of hypersensitivitysuch as itching, and should ask for medical advice whenobserving any indicative sign or symptoms. Patients should beadvised to stop the drug immediately if they develop any type of eaction and contact their physicians as soon as possible. • Serious Skin Reactions, including DRESS: Advise patients to stop taking ibuprofen tablets immediately if they develop any type of reaction 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 ofhepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice,right upper quadrant tenderness and “flu-like” symptoms).

If theseoccur, patients should be instructed to stop therapy and seek immediatemedical therapy. • Patients should be informed of the signs of an anaphylactoid reaction(e.g. difficulty breathing, swelling of the face or throat). If theseoccur, patients should be instructed to seek immediate emergencyhelp (see WARNINGS) . • In late pregnancy, as with other NSAIDs, Ibuprofen tablets should beavoided because it may cause premature closure of the ductus arteriosus.

Clinical Considerations Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus:Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Ibuprofen, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity ). Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.

If Ibuprofen treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Ibuprofen and follow up according to clinical practice (see WARNINGS; Fetal Toxicity ). Data Human Data There are no adequate, well-controlled studies in pregnant women.

Ibuprofen tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Premature Closure of Fetal Ductus Arteriosus: There are no adequate, well-controlled studies in…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Non-Steroidal 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: ° with increasing doses of NSAIDs ° 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: ° anytime during use ° without warning symptoms ° that may cause death The risk of getting an ulcer or bleeding increases with: ° past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs ° taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" ° increasing use of NSAIDs ° longer use of NSAIDs ° smoking ° drinking alcohol ° older age ° poor health ° advanced liver disease ° bleeding problems NSAIDs should only be used : ° exactly as prescribed ° at the lowest dose possible for your treatment ° 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 NSAIDs? Do not take NSAIDs: • if you 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 your medical conditions, including if you: • have liver or kidney problems • have high blood pressure • have asthma • are pregnant or plan to become pregnant.

Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 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 Nonsterodial Anti-Inflammatory Drugs (NSAIDs)?" • new or worse high blood pressure • low red blood cells (anemia) • heart failure • life-threatening skin reactions • liver problems including liver failure • life-threatening allergic reactions • kidney problems including kidney failure • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you have 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 your NSAID medicine and call your healthcare provider right away if you have 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 reaction or blisters with fever • your skin or eyes look yellow • swelling of t…

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