FDA label 4acde475-a74f-17db-e054-00144ff8d46c

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
8181805a-12f4-44f0-8f5b-6168f0d99e7d
SPL ID
4acde475-a74f-17db-e054-00144ff8d46c
Version
2
Effective date
2017-03-15
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:05

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 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 chances are 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 •if you have ever had an allergic reaction to any other pain reliever/fever reducer•right before or after heart surgery •you have problems or serious side effects from taking pain relievers or fever reducers•the 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, or kidney disease•you have asthma•you are taking a diuretic •taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin•under a doctor’s care for any serious condition•taking any other drug •take with food or milk if stomach upset occurs•the risk of heart attack or stroke may increase if you use more than directed or for longer than directed •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•pain gets worse or lasts more than 10 days•fever gets worse or lasts more than 3 days•redness or swelling is present in the painful area•any new symptoms appear ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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