FDA label e062be99-7796-47ba-a846-295a74797343

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
413789cc-60ce-45f0-80c5-cb3de3e96a62
SPL ID
e062be99-7796-47ba-a846-295a74797343
Version
4
Effective date
2023-09-16
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 02:31:33

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 ulcer 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 any other pain reliever/fever reducer 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 asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for ◾ gout ◾ diabetes ◾ 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 more than 10 days ◾ redness or swelling is present ◾ fever lasts more than 3 days ◾ new symptoms occur ◾ ringing in the ears or a 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 definitely 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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