FDA label d8b63309-b473-4a68-af59-a1192ff75584

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
5441bffb-b2e5-4b65-bdde-a1d072d683db
SPL ID
d8b63309-b473-4a68-af59-a1192ff75584
Version
10
Effective date
2018-12-17
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:04

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 • facial swelling • shock • asthma(wheezing) Stomach Bleeding Warning : This product contains an NSAID, which may cause stomach bleeding. The chance is higher if the user: • is age 60 or older • has had stomach ulcers or bleeding problems • takes a blood-thinning (anticoagulant) or steriod drug • takes other drugs containing prescription or nonprescription NSAIDS (aspirin,Ibuprofen, naproxen, or others) • takes more or for a longer time than directed • has 3 or more alcoholic drinks every day while using this product Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer. Ask a doctor before use if • stomach bleeding warning applies to user • user has a history of stomach problems, such as heartburn • user has high blood pressure, heart disease, liver cirrhosis, or kidney disease • user is taking a diuretic • user has asthma • user has not been drinking fluids • user has lost a lot of fluid due to vomiting or diarrhea Ask a doctor or pharmacist before use if the user is • taking a prescription drug for diabetes, or gout or arthritis • taking any other drug • under a doctor's care for any serious condition Stop use and ask a doctor if • user experiences any ot the following signs of stomach bleeding: • °feels faint °has bloody or black stools °vomits blood °has stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear • ringing in the ears or a 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.