FDA label 8c174fea-0c59-4e24-baf0-e767f2dc572b

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
8c174fea-0c59-4e24-baf0-e767f2dc572b
SPL ID
8c174fea-0c59-4e24-baf0-e767f2dc572b
Version
1
Effective date
2011-04-17
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:47

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: facial swelling asthma (wheezing) shock hives Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers. Ask a doctor before use if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back or allergic reaction to aspirin bleeding problems ulcers asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes gout arthritis anticoagulation ( thinning of blood) Indicated for pain relief. Stop use and ask a doctor if An allergic reaction occurs. Seek medical help right away Pain gets worse or lasts more than 10 days Redness or swelling is present New symptoms occur Ringing in the ears or loss of hearing occurs. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during 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. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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