FDA label 5108bdca-1454-4353-b55f-e31da8ed4f4f

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
73859ea9-01a0-4c3d-97d4-17b9d3378899
SPL ID
5108bdca-1454-4353-b55f-e31da8ed4f4f
Version
1
Effective date
2010-11-30
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:10

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: Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu 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. 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 doctor before using if you have: Asthma Bleeding problems Stomach problems (such as heartburn, upset stomach or stomach pain) gastric ulcers 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 If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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.