FDA label 3afa1966-3613-4e1b-b9ab-5b2712df183e

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
50c157d7-ea12-4a55-82ba-4190bd1fd4c5
SPL ID
3afa1966-3613-4e1b-b9ab-5b2712df183e
Version
2
Effective date
2012-08-02
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 03:02:10

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 Children and teenagers who have or are recovering from chicken pox or flulike Reyeʼs syndrome: 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. Aspirin may cause a severe allergic reaction, which may include: Allergy alert: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing) This product contains an NSAID, which may cause severe stomach Stomach bleeding warning: 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 ■ if you are allergic to aspirin or any other pain reliever/fever reducer Do not use ■ stomach bleeding warning applies to you Ask a doctor before use if ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have asthma ■ you have not been drinking fluids ■ you have lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if you are ■ taking a prescription drug for diabetes, gout, or arthritis ■ under a doctor’s care for any serious condition ■ taking any other drug ■ you experience any of the following signs of stomach bleeding: Stop use and ask a doctor if ■ feel faint ■ have bloody or black stools ■ vomit blood ■ have stomach pain that does not get better ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear ■ ringing in the ears or a loss of hearing occurs , ask a health professional before use. It is especially important not If pregnant or breast-feeding to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Reported adverse events (FAERS/openFDA)#

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