FDA label 7ed49f9c-3902-4dac-9220-01cd9851bd31

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
e25eed0d-183b-45f9-9f33-f5e78be4f430
SPL ID
7ed49f9c-3902-4dac-9220-01cd9851bd31
Version
6
Effective date
2017-08-09
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:37:04

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

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, seek medical help right away. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you: Are 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen, naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed. Do not use if you have ever had a n allergic reaction to any other pain reliever / fever reducer or right before / 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 haev 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. Ask a doctor or pharmacist before use if you are: 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. 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 of 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 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. 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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Reported adverse events (FAERS/openFDA)#

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