FDA label 2a8902c7-0a86-5d9e-e063-6394a90a4198

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
c623d479-f7c9-da5d-e053-2a95a90a898a
SPL ID
2a8902c7-0a86-5d9e-e063-6394a90a4198
Version
6
Effective date
2024-12-30
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:31:52

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 Warnings Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include - hives - facial wseelling - shock - astham (wheezing) This product contains soy Stomach bleeding warning: This product contains an NSAID, which may cause 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 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

Reported adverse events (FAERS/openFDA)#

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