FDA label 37b07cab-8b96-1c32-e054-00144ff88e88

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
80ee1531-0c55-47ab-a39d-0cbdec2796fa
SPL ID
37b07cab-8b96-1c32-e054-00144ff88e88
Version
19
Effective date
2016-07-15
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 05:13:19

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

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 serius illness reported to be associated with aspirin. Allergy Alert: Aspirin may cause a severe allergic reaction which may include Hives, Facial Swelling, Asthma, Shock. Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (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 blood thinner (anti-coagulant) or steriod drug, have 3 or more alcoholic drinks every day ehile using this product, take more or for a longer time than directed, 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 a sodium restricted diet. Stop use and ask a doctor if you experience any of the following signs of stomach bleeding, feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, do not take more than the reecommended dosage

Reported adverse events (FAERS/openFDA)#

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