FDA label 4614656c-9fc8-c5a0-e063-6394a90a03fc

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
f059734d-7458-c9c6-e053-2a95a90a2f63
SPL ID
4614656c-9fc8-c5a0-e063-6394a90a03fc
Version
4
Effective date
2025-12-16
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:52

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: Contains salicylate. Do not take if you are •allergic to salicylates (including aspirin) •taking other salicylate products Do not use if you have •bloody or black stool •an ulcer •a bleeding problem Ask a doctor before use if you have •fever •mucus in the stool Ask a doctor before use if you are taking any drug for •anticoagulation (thinning of the blood) •diabetes •gout •arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if •symptoms get worse or last more than 2 days •ringing in the ears occurs or loss of hearing occurs •diarrhea lasts more than 2 days If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.1-800-222-1222.

warnings

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

Reported adverse events (FAERS/openFDA)#

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