FDA label a04a4e04-5507-4b2e-84a2-ec644eb23d0c

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
0415a522-06cf-4ab0-84a4-3c017a317b0b
SPL ID
a04a4e04-5507-4b2e-84a2-ec644eb23d0c
Version
2
Effective date
2018-12-07
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:30:45

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 chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed. have 3 or more alcoholic drinks every day while using this product Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery unless you have time for a full night’s sleep with any other product containing diphenhydramine , even one used on skin if you have sleeplessness without pain Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have glaucoma you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers. you have a breathing problem such as emphysema or chronic bronchitis you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid taking any other drug taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any continuing medical illness When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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 stools have stomach pain that does not get better pain gets worse or last more than 10 days sleepnessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness redness or swelling is present in the painful area any new symptoms appear. If pregnant of breast-feeding, 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. Keep out of reach of children In case of overdose, get medical help or contact a poison control center right away

Reported adverse events (FAERS/openFDA)#

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