FDA.reportPublic FDA data

FDA label e221bbce-83e0-0f03-e053-2995a90abca5

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
96391d94-678b-41d7-e053-2a95a90adf33
SPL ID
e221bbce-83e0-0f03-e053-2995a90abca5
Version
5
Effective date
2022-06-23
Source export date
2026-08-08
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/f9914d64bdcd01a4629905fd6421fbe60196ad98c430d1a297f4114fa869f148/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:18:42

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: Contains salicylate. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products