FDA label 5a3410c9-13fe-4a60-ac69-bb16f1c6d8d4

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
95d75fd9-ad5f-4b5c-82c1-6c2b8ffc5f4a
SPL ID
5a3410c9-13fe-4a60-ac69-bb16f1c6d8d4
Version
4
Effective date
2017-06-15
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:43

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 **Aspirin is not appropriate for eveyone, so be sure to talk to you doctor before you begin and aspirin regimen. Do not use • •if you have ever had an allergic reaction to any other pain reliever/fever reducer • •for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor Ask a doctor before use if • •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • •stomach bleeding warning applies to you • •you have a history of stomach problems, such as heartburn • •you are taking a diuretic • •you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or 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 • •pain gets worse or lasts for more than 10 days • •fever gets worse or lasts for more than 3 days • •redness or swelling is present • •new symptoms occur • •ringing in the ears or loss of hearing occurs These could be signs of a serious condition 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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Warning: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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