FDA label cf871088-1c6c-443c-a548-bd0586d3a00e

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
7eb06d18-08b8-41c9-a3ed-7bbc5d69c0b5
SPL ID
cf871088-1c6c-443c-a548-bd0586d3a00e
Version
3
Effective date
2021-10-07
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:51:38

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 an 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 ulders or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks everyday while using this prdouct take more or for a longer time than directed Heart attack and 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 if you ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if 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, kidney disease, asthma, or had a stroke you are taking a diuretic. Ask a doctor or pharmacist before use if you are taking aspirin for 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. When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke chest pain slurred speech leg swelling trouble breathing weakness in one part or side of body 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 If pregnant or breast-feeding ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. 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.