FDA label d267d8f5-1f6a-4bf2-92d7-256215e048f3

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
052c35dc-e8b4-49e5-b626-2abba46e8dc8
SPL ID
d267d8f5-1f6a-4bf2-92d7-256215e048f3
Version
2
Effective date
2019-10-01
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:49:42

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 should not use this medicine for chicken pox or -u symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. 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 are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an allergic reaction to any other pain reliever/fever reducer • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor • with any other product containing aspirin Ask a doctor before using if you have: • asthma • gastric ulcers • bleeding problems • stomach problems (such as heartburn, upset stomach or stomach pain) Ask a doctor or pharmacist before use if you are taking a prescription drug for: • anticoagulation (thinning of blood) • diabetes • gout • arthritis Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present When using this product do not exceed recommended dose

Reported adverse events (FAERS/openFDA)#

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