FDA label 9fa0758c-8d54-433e-9d05-9bea0c14a62a

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
f82a3ca9-e2fd-4797-a881-4b9bc68ab093
SPL ID
9fa0758c-8d54-433e-9d05-9bea0c14a62a
Version
2
Effective date
2017-06-16
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:40

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 This package is intended for institutional use only. 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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. 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, shock, asthma (wheezing). 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. Ask a doctor before use if you have asthma, ulcers, bleeding problems, stomach problems (such as heartburn, upset stomach or stomach pain) that persist or recur. Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (blood thinning), gout, diabetes, or arthritis. Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away if new symptoms occur, pain gets worse or lasts more than 10 days, redness or swelling is present ringing in the ears or loss of hearing occurs.

Reported adverse events (FAERS/openFDA)#

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