FDA label 62df5f70-2fbf-4620-ab95-09680d33f306

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
845b4bca-fb49-4a98-8ddf-b44320850d84
SPL ID
62df5f70-2fbf-4620-ab95-09680d33f306
Version
2
Effective date
2013-03-05
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:50:15

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: • shock • hives • facial swelling • asthma (wheezing) • rash • skin reddening • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains a nonsteroidal 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. Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are the 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 more than 10 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear. Ask a doctor before 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 • bleeding problems • ulcers • high blood pressure • taken a diuretic • heart or kidney disease • reached age 60 or older. Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or non prescription) • taking a blood thinning agent (anticoagulant) or steroid drug • taking any other drug • under a doctor’s care for any serious condition.

Reported adverse events (FAERS/openFDA)#

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