FDA label 404ccd8d-dba1-4d27-8e1f-9ddda1fe4fa4

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
2a8d1e14-ffb6-49ad-95b0-ad3fe34bfc49
SPL ID
404ccd8d-dba1-4d27-8e1f-9ddda1fe4fa4
Version
3
Effective date
2024-06-26
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:16

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 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 oder 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. 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 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 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 the risk of heart attack or stroke may increase if you use more than directed or for longer than directed. 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 stoolos have stomach pain that does not bet better Pain gets worse or last more than 10 days Fever gets worse or last more than 3 days Redness or swelling is presentin 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) Directions do not take more than directed the smallest effective dose should be used 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 : Other information store between 20 o - 25 o C (68 o - 77 o F) read all warnings and directions before use. Keep carton do not use if imprinted foil under cap is broken or missing † This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®

warnings table

<table><col/><col/><col/><col/><tbody><tr><td colspan="3"> Adults and children 12 years and older</td><td><list listType="unordered" styleCode="Disk"><item>take 1 tablet every 4 to 6 hours while symptoms persist </item><item>if pain or fever does not respond to 1 tablet, 2 tablets may be used. </item><item>do not exceed 6 tablets in 24 hours, unless directed by a doctor</item></list></td></tr><tr><td colspan="3"> children under 12 years</td><td><list listType="unordered" styleCode="Disk"><item> ask a doctor</item></list></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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