FDA label 9855efa4-bfa0-392c-e053-2a95a90a8a5a

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
56c087e9-bfca-4b28-838a-5036b487e151
SPL ID
9855efa4-bfa0-392c-e053-2a95a90a8a5a
Version
2
Effective date
2019-11-27
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:12:29

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 shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user 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 is age 60 or older

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>shock</item> <item>facial swelling</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>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> <item>is age 60 or older</item> </list> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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