FDA label fdc4cdb4-88db-4195-a574-709f5d0f2b78

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
8ac617a6-fb86-4ae9-afd6-4e839c05c97c
SPL ID
fdc4cdb4-88db-4195-a574-709f5d0f2b78
Version
2
Effective date
2015-05-11
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:36:51

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 ■ asthma (wheezing) ■ shock 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 other pain relievers/fever reducer. Ask a doctor before use if ■ the stomach bleeding warning applies to you ■ you have history of stomach problems, such as heartburn ■ you have liver cirrhosis ■ you have asthma ■ you have high blood pressure ■ you have heart or kidney disease ■ you have taken a diuretic Ask a doctor or pharmacist before use if you are ■ taking any other drug containing an NSAID (prescription or nonprescription) ■ taking a blood thinning (anticoagulant) or steroid drug ■ taking a prescription drug for diabetes, gout or arthritis 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 ■ an allergic reaction occurs. Seek medical help right away. ■ pain gets worse or lasts for more than 10 days ■ redness or swelling is present ■ fever gets worse or lasts more than 3 days ■ any 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Directions ■ drink a full glass of water with each does ■ adults: 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. ■ children under 12: consult a doctor. Other information ■ store at room temperature Inactive ingredients starch

Reported adverse events (FAERS/openFDA)#

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