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Ibuprofen Thompson

Ibuprofen · Tablet, Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ibuprofen Thompson
Generic name
Ibuprofen
Dosage form
Tablet, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Thompson Safety
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibuprofen 200 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
075010
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 1, 1999
Sponsor
LNK
Products on application
1
Submissions recorded
9
Products approved under application 075010.
Product Trade name Form Strength Ingredient Status TE Flags
075010-001 IBUPROFEN TABLET IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 075010.
Type No. Action Status Date Review
Supplement 9 Labeling Approved May 1, 2015 —
Supplement 7 Supplement Approved November 4, 2005 —
Supplement 6 Supplement Approved July 19, 2004 —
Supplement 4 Supplement Approved August 5, 2003 —
Supplement 5 Supplement Approved February 4, 2003 —
Supplement 3 Labeling Approved August 15, 2002 —
Supplement 2 Manufacturing (CMC) Approved September 27, 2001 —
Supplement 1 Manufacturing (CMC) Approved November 20, 2000 —
Original application 1 Approved March 1, 1999 —

Review documents

  • 0 · Original application · July 20, 2007
  • 0 · Supplement · July 20, 2007
  • 0 · Supplement · July 20, 2007
  • 0 · Supplement · July 20, 2007
  • 0 · Original application · March 1, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250908). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250908

Indications and Usage

openFDA Drug Labeling

Uses Temporarily relieves minor aches and pains associated with ■ headache ■ toothache ■ backache ■ menstrual cramps ■ common cold ■ muscular aches ■ minor arthritis pain Temporarily reduces fever.

Purpose

openFDA Drug Labeling

Purpose Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions ■ do not use more than directed ■ the smallest effective dose should be used ■ do not take longer than 10 days, unless directed by a doctor (see Warnings) Adults and children:(12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: Ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use

openFDA Drug Labeling

Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ stomach bleeding warning applies to you ■ you have a history of stomach problems such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke ■ you are taking a diuretic

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ you have symptoms of heart problems or stroke ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ redness or swelling is present in the painful area ■ any new or unexpected symptoms occur

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
73408-509-33 73408-509 Thompson Safety 50 PACKET in 1 BOX (73408-509-33) / 2 TABLET, COATED in 1 PACKET October 4, 2021
73408-809-33 73408-809 Thompson Safety 50 PACKET in 1 BOX (73408-809-33) / 2 TABLET, COATED in 1 PACKET October 4, 2021
73408-509 73408-509 Thompson Safety — October 4, 2021
73408-809 73408-809 Thompson Safety — October 4, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.