FDA label 44eb1098-8a54-37b5-e063-6294a90a4650

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
e5b51379-40d9-4fbd-b1aa-0994c854572c
SPL ID
44eb1098-8a54-37b5-e063-6294a90a4650
Version
5
Effective date
2025-12-01
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:47

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 with may included hives, facial swelling, asthma (wheezing) and shock Stomach Bleeding Warning : this product containers 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 or any other pain relievers / fever reducers If you have ever had an allergic reaction to this product or any of its ingredients 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 have asthma You have taken a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of the blood), diabetes, gout, 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 New symptoms occur Redness or swelling is present Ringing in the ears or loss of hearing occurs Pain gets worse or lasts more than 10 days You may report serious side effects to 1-888-952-0050 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 delivery.

Reported adverse events (FAERS/openFDA)#

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