FDA label 67601058-9eec-4e7c-b948-942dd62a775f

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
3a3cd47e-1ee5-4e26-baa3-da2786c1a595
SPL ID
67601058-9eec-4e7c-b948-942dd62a775f
Version
1
Effective date
2015-01-03
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:21

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 reducers 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 have asthma ■ you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis Stop use and ask a doctor if ■ an allergic reaction occurs. Seek medical help right away ■ 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 ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days 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 and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ children under 12 years: consult a doctor Other information ■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing You may report serious side effects to 1-888-952-0050 Inactive ingredients Acetylated monoglycerides, corn starch, croscarmellose sodium, D&C Yellow 10, FD&C Yellow #6, hypromellose, hypromellose phthalate, microcrystalline cellulose, mineral oil, polyethylene glycol 400, polysorbate 80, titanium doxide

Reported adverse events (FAERS/openFDA)#

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