FDA label 1ceecc79-bbc5-46d2-e063-6294a90ab452

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
ad55db20-46c1-eed0-e053-2995a90aaa84
SPL ID
1ceecc79-bbc5-46d2-e063-6294a90ab452
Version
5
Effective date
2024-07-10
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:06

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

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: ■ Asthma (wheezing) ■ Hives ■ Facial swelling ■ Shock Stomach bleeding warning: This product contains an 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 NSAlDs (e.g. aspirin, ibuprofen, naproxen, or others) ■ takes more than directed or for a longer time than directed ■ is age 60 or older ■ has 3 or more alcoholic drinks per day while using this product Ask a doctor before use Ask a doctor before use if you have: ■ a history of stomach problems, such as heartburn ■ high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ taken a diuretic ■ not been drinking fluids ■ lost a lot of fluid due to vomiting or diarrhea Stop use Stop use of this product and ask a healthcare provider if user experiences any of the lollowing signs or stomach bleeding: feels faint ■ vomits blood ■ has bloody or black stools ■ has stomach pain that does not get better Pregnancy: If pregnant or breast-feeding If pregnant or breast-feeding always ask your healthcare provider before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed to do so by a doctor as it may cause problems in the unborn child or complications during delivery. Do not use Do not use: If you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems, unless directed by a doctor. If allergic to milk and/or egg white, or have ever had an allergic reaction to this product or any of its ingredients. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult your healthcare provider. Keep out of the reach of children Children Warning: 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.