FDA label 57eae88b-ceae-44d1-a5df-3e96ee226643

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
3dcf9e68-10d7-4a67-a250-9c786d25bc06
SPL ID
57eae88b-ceae-44d1-a5df-3e96ee226643
Version
3
Effective date
2022-12-30
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:02

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 • With 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 Ask a doctor before use if: • The stomach bleeding warning applies to you • You have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma, or kidney disease • You are taking a diuretic • You have a history of stomach problems such as heartburn Ask a doctor or pharmacist before use if are taking a prescription drug for: • Anticoagulation (thinning of blood) • Diabetes • Gout • Arthritis When using this product do not exceed recommended dose 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 • 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, 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 pregnancy. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms. Directions Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years of age: Ask a doctor. Other Information • Do not use if packet is torn, cut, or opened • Store at room temperature • Avoid excessive heat and humidity Questions? 1-800-327-2704 M – F 8AM – 5PM (CDT) 2 tablets per packet

Reported adverse events (FAERS/openFDA)#

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