FDA label 6e8d8fde-2617-4880-9cc1-0f036cb71093

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
509c0a20-e8b5-499b-8c78-cd94b9bafa2a
SPL ID
6e8d8fde-2617-4880-9cc1-0f036cb71093
Version
1
Effective date
2014-04-07
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:27

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), and 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 or 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 a high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma or had a tonsillectomy or oral surgery in the last 7 days. Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes, arthritis or anticoagulation. Stop and ask a doctor if an allergic reaction occurs (seek medical help right away), if you experience any of the following signs of stomach bleeding (feel faint, vomit blood, have bloody or black stools, stomach pain that does not get better), pain gets worse or lasts more than 10 days, fever lasts more than 3 days, redness or swelling is present, new symptoms occur, ringing in the ears or 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 right away.

Reported adverse events (FAERS/openFDA)#

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