FDA label f1f051d8-b8d8-4afd-84d8-82a59d9fa4fb

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
f1f051d8-b8d8-4afd-84d8-82a59d9fa4fb
SPL ID
f1f051d8-b8d8-4afd-84d8-82a59d9fa4fb
Version
1
Effective date
2014-07-01
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:05:38

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS Allergy alert: Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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 prescription or nonprescription NSAIDs [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

warnings

OTHER REQUIRED WARNINGS each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Reported adverse events (FAERS/openFDA)#

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