Ibuprofen

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Ibuprofen
Generic name
IBUPROFEN
Manufacturer
PROSTAT FIRST AID
Product type
HUMAN OTC DRUG
SPL set ID
3bca27b4-3df6-b7d1-e063-6394a90ac6af
SPL ID
3bca27c2-b039-32ae-e063-6294a90a72ee
Version
1
Effective date
2025-08-07
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:39
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert Ibuprofen may cause severe allergic reactions, especially in people allergic to aspirin. Symptoms may include hives facial swelling asthma (wheezing) shock skin reddening rash blisters if an allergic reaction occurs, stop use and seek medical help right away Stomach Bleeding Warning This product contains a NSAID, which may cause severe stomach bleeding. The chances are higher if you: are age 60 or older have stomach ulcers or bleeding problems take 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. Contains FD+C Yellow No. 5 (tartrazine) as a color additive

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.