FDA label 8e07de78-91bb-47d2-9586-6521912cbca6

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
a4c8e1fd-e86b-4894-bc6a-2539a2812060
SPL ID
8e07de78-91bb-47d2-9586-6521912cbca6
Version
6
Effective date
2017-08-08
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:53

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

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 NSAID, which may cause severe stomach bleeding. The chance is higher if the user: -Has had stomach ulcers or bleeding problems -Takes a blood thinning (anticoagulant) or steroid drug -Takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) -Takes more or for a longer time than directed -Is age 60 or older -Has 3 or more alcoholic drinks every day while using this product Do not use: if you are allergic to aspirin or other pain relievers / fever reducers. For at least 7 days after tonsillectomy or oral surgery unless directed by a doctor. Ask a doctor before use if: -Stomach bleeding warning applies to user -user has history of stomach problems, such as heartburn -User has high blood pressure, heart disease, liver cirrhosis, or kidney disease -User is taking a diuretic -You have asthma Ask a doctor of pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis. Stop use and ask a doctor if: -User experiences any of the following signs of stomach bleeding: feels faint, vomits blood, has bloody or black stools, has stomach pain that does not get better -An allergic reaction occurs. Seek medical help help right away -New symptoms occur -Redness or swelling is present -Pain gets worse or lasts for more than 10 days -Ringing in the ears or loss of hearing occurs -You may report side effects to 1-888-952-0050 If p regnant 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 unborn child or complications during delivery.

Reported adverse events (FAERS/openFDA)#

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