FDA label e90e4cbe-9b41-db40-e053-2a95a90a5011

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
9636177c-a618-dc5f-e053-2995a90a9f2c
SPL ID
e90e4cbe-9b41-db40-e053-2a95a90a5011
Version
4
Effective date
2022-09-19
Source export date
2026-08-17
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/2026-08-17/860dc0eef34653a2a2dab2761771be9cda8410b7a1f078032b37381cbdbb4107/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:31:13

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 shock acial swelling asthma (wheezing) If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID , which may cause severe stomach bleeding. The chance is higher if you: have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescriptionNSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed are age 60 or older have 3 or more alcoholic drinks everyday while using this product 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or 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 pain persist, gets worse or last for more than 10 days ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is very important not to use aspirin during the last 3 months of pregnancy unless 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.