FDA label 483331a7-a3a3-f610-e063-6394a90aeeec

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
8fbde87b-d0d9-4a62-b8a3-9320cbb727a5
SPL ID
483331a7-a3a3-f610-e063-6394a90aeeec
Version
7
Effective date
2026-01-12
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:27:43

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 wich may include: hives facial swelling asthma (wheezing) shock. Alcohol warning If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relieves/fever reducers. Ibuprofen may cause stomach bleeding. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer. When using this product take with food or milk if stomach upset occurs. I f pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or c omplications during delivery.

Reported adverse events (FAERS/openFDA)#

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