FDA label 2a4f4d62-24f4-46fe-a5b8-24da41bbcb74

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
071b859b-4cf9-4e84-a0af-b9a026a96cc1
SPL ID
2a4f4d62-24f4-46fe-a5b8-24da41bbcb74
Version
2
Effective date
2025-05-12
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:54:06

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

Warning 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 • facial swelling • shock • hives • asthma (wheezing) 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 • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • take more or for a longer time than directed • have had stomach ulcers or bleeding problems • 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 • this product 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 you • you have a history of stomach problems, such as heartburn • you are taking a diuretic • you have asthma • you have high blood pressure, heart disease, liver cirrhosis or kidney disease 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 • 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 • an allergic reaction occurs • any new symptoms occur • pain gets worse or lasts more than 10 days • redness or swelling is present • ringing in the ears or loss of hearing occurs These could be signs of a serious illness. 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 accidental 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.