FDA.reportPublic FDA data

FDA label 719d27f5-40e3-4e71-9df6-504324e2e99d

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)

SPL set ID
7cc53a7b-dff7-487a-b0e2-eef7f69b83ef
SPL ID
719d27f5-40e3-4e71-9df6-504324e2e99d
Version
2
Effective date
2025-05-16
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:20:39

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, 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 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks everyday while using this product • take more or for a longer time than directed

warnings and cautions

Allergy alert: Ibuprofen may cause a severe allergic reaction, 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 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks everyday while using this product • take more or for a longer time than directed

warnings and cautions

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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks everyday while using this product • take more or for a longer time than directed

Reported adverse events (FAERS/openFDA)#

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