FDA label 3ba085f8-2eeb-8958-e063-6394a90a7739

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
cc7013ea-cf30-6f59-e053-2a95a90a1148
SPL ID
3ba085f8-2eeb-8958-e063-6394a90a7739
Version
5
Effective date
2025-08-05
Source export date
2026-10-30
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/2026-10-30/57469fe40e5b1c0d9604dc7dbc22532ea48e8e53acfb911fc676578d98492f7e/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 18:30:16

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 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 Swelling · Shock · Asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach 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 Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if · Stomach bleeding warning applies to you · 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 a 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 Stop use and ask a doctor if · You experience any of the following signs of stomach bleeding · 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problem in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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