FDA label 217d7ff8-6f52-4a8b-9e25-4b66b06c2178

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
f7d726ae-a9d6-464a-86c8-c2bb36f792be
SPL ID
217d7ff8-6f52-4a8b-9e25-4b66b06c2178
Version
2
Effective date
2014-04-08
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:20

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (ibuprofen, naproxen or others) • _ are age 60 or older • _ take more or for a longer time than directed • _ have 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 you have • problems or serious side effects from taking pain relievers or fever reducers • high blood pressure • stomach problems that last or come back, such as heartburn, upset stomach or stomach pain • heart or kidney disease • ulcers • asthma • reached age 60 or older • taken a diuretic • bleeding problems Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • taking a prescription drug for diabetes, gout or arthritis • taking any other drug • under a doctor’s care for any serious condition Stop use and ask a doctor if • any new symptoms appear • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • stomach pain or upset gets worse or lasts • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • 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.

Reported adverse events (FAERS/openFDA)#

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