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
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:01:07

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.