FDA label f2720a2b-6a39-2e6f-e053-2a95a90a9552

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
89a96333-97c2-4fb4-a5d3-a2c829a63685
SPL ID
f2720a2b-6a39-2e6f-e053-2a95a90a9552
Version
4
Effective date
2023-01-17
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:55:44

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 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 severe 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 steroid 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

warnings table

<table border="0" width="100%"><tbody><tr><td><paragraph><content styleCode="bold">Warnings Reye&apos;s syndrome: </content></paragraph><paragraph>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&apos;s syndrome, a rare but serious illness. </paragraph><paragraph><content styleCode="bold">Allergy alert:</content></paragraph><paragraph>Aspirin may cause a severe allergic reaction which may include </paragraph><list listType="unordered"><item>hives</item><item>facial swelling</item><item>shock</item><item>asthma (wheezing)</item></list><paragraph><content styleCode="bold">Stomach bleeding warning:</content></paragraph><paragraph>This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user: </paragraph><list listType="unordered"><item>is age 60 or older</item><item>has had stomach ulcers or bleeding problems</item><item>takes a blood thinning (anticoagulant) or steroid drug</item><item>takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)</item><item>takes more or for a longer time than directed</item><item>has 3 or more alcoholic drinks every day while using this product</item></list></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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