FDA label c62a04fc-686f-112d-e053-2a95a90ae61e

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
45eb33f0-71e2-11d5-e054-00144ff88e88
SPL ID
c62a04fc-686f-112d-e053-2a95a90ae61e
Version
3
Effective date
2021-07-02
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 05:31:32

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 ■ blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach Bleeding Warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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. Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery Ask a doctor use if you have: ■ problems or serious side effects from taking pain relievers or fever reducers ■ stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ■ ulcers ■ bleeding problems ■ high blood pressure ■ heart disease, liver cirrhosis, or kidney disease ■ taken a diuretic ■ reached age 60 or older Ask a doctor or pharmacist before use if you are: ■ taking any other drug containing as NSAID (prescription or non-prescription) ■ taking a blood thinning (anti-coagulated) or steroid drug ■ 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 ■ long term continuous use may increase the risk of heart attack or stroke. Stop use and ask a doctor if: ■ you feel faint, vomit blood or have bloody or black stools. These are signs of stomach bleeding ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ stomach pain or upset gets worse or lasts ■ 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 during the last 3 months of pregnancy unless specially 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.