FDA label 98cf3386-e531-6fd3-e053-2a95a90a3de7

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
34b224d4-5162-4019-9604-da67a36e6e44
SPL ID
98cf3386-e531-6fd3-e053-2a95a90a3de7
Version
3
Effective date
2019-12-03
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:12:11

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 older; have had stomach ulcers or bleeding problems; take a blood thinning (anticoagulant) or steroid drug; take more or for a longer time than directed.

warnings table

<table border="0" width="100%"> <tbody> <tr> <td> <paragraph> <content styleCode="bold">WARNINGS:</content> </paragraph> <paragraph> <content styleCode="bold">Reye&#x2019;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&#x2019;s Syndrome, a rare but serious illness.</content> </paragraph> <paragraph/> <paragraph> <content styleCode="bold">Allergy Alert: Aspirin may cause a severe allergic reaction, which may include hives, facial swelling, shock, asthma (wheezing)</content> </paragraph> <paragraph/> <paragraph> <content styleCode="bold">Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are: age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinning (anticoagulant) or steroid drug; take more or for a longer time than directed.</content> </paragraph> </td> </tr> </tbody> </table>