FDA label 98cffa3c-4416-6a1d-e053-2995a90abcaf

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
76a21494-8c94-4da0-9608-fc70f787f070
SPL ID
98cffa3c-4416-6a1d-e053-2995a90abcaf
Version
6
Effective date
2019-12-03
Source export date
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:04

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 you: _ are age 60 or olde r

warnings table

<table border="0" width="100%"> <tbody> <tr> <td> <paragraph> <content styleCode="bold"> <content styleCode="italics">Warnings</content> </content> </paragraph> <paragraph> <content styleCode="bold">Reye&#x2019;s syndrome: </content>Children and teenagers who have or </paragraph> <paragraph>are recovering from chicken pox or flu-like symptoms</paragraph> <paragraph>should not use this product. When using this product,</paragraph> <paragraph>if changes in behavior with nausea and vomiting occur,</paragraph> <paragraph>consult a doctor because these symptoms could be an</paragraph> <paragraph>early sign of Reye&apos;s syndrome, a rare but serious</paragraph> <paragraph>illness.</paragraph> <paragraph> <content styleCode="bold">Allergy alert: </content>Aspirin may cause a severe allergic </paragraph> <paragraph>reaction, which may include: _ hives</paragraph> <paragraph>_ facial swelling _ shock _ asthma (wheezing)</paragraph> <paragraph> <content styleCode="bold">Stomach bleeding warning: </content>This product contains an </paragraph> <paragraph>NSAID, which may cause severe stomach bleeding.</paragraph> <paragraph>The chance is higher if you: _ are age 60 or olde</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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