FDA label 338899f5-9a3d-436d-bcb3-ba988abf03ac

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
abd781d2-b94c-4527-91a9-5abf7bd875de
SPL ID
338899f5-9a3d-436d-bcb3-ba988abf03ac
Version
5
Effective date
2025-04-04
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:26:35

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 should not use this drug for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • Hives • facial swelling • asthma (wheezing) • shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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. Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. Do Not Use • if you have ever had an allergic reaction to any other pain reliever/fever reducer • if you are allergic to aspirin • if overly full from food or drink. Ask a doctor if sever stomach pain occurs after taking this product. Ask 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 Ask Doctor/Pharmacist before use if you are • presently taking a prescription drug. Antacids may interact with certain prescription drugs. • taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis When Using this product do not take more than 8 tables (adults) and 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days. 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. Seek medical help right away. • pain lasts for more than 10 days or gets worse • new symptoms occur • redness or swelling is present • ringing in the ears or a loss of hearing occurs If pregnancy 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.