FDA label 6f51494d-d3b6-45ab-884f-8b1c729cbea9

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
27374ea7-8e0b-4764-b630-f4388663f9c8
SPL ID
6f51494d-d3b6-45ab-884f-8b1c729cbea9
Version
3
Effective date
2018-07-24
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:22

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 medicine 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 allert Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock 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 Ask a doctor before use if you have • been placed on a sodium restricted diet • asthma • ulcers • bleeding problems • stomach problems that last or come back, such as heartburn, upset stomach or pain Ask a doctor or 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 exceed the recommended dosage Stop use and ask a doctor if • 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 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.