FDA label e272c1cf-9795-0abd-e053-2995a90a2229

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
e272c1cf-9793-0abd-e053-2995a90a2229
SPL ID
e272c1cf-9795-0abd-e053-2995a90a2229
Version
1
Effective date
2022-06-27
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 05:16:06

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 or vomiting occur, consult a doctor 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 salicylate (including aspirin) taking other salicylate products Do not use if you have an ulcer bleeding problem bloody or black stool. Ask a doctor before use if you have fever mucus in stool. Ask a doctor or pharmacist before use if you are taking any drugs for: anticoagulation (thinning 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 ringing in ears or loss of hearing occurs if diarrhea lasts more than 2 days. If pregnant or breast-feeding , ask a health professional before use. Keep out of the reach of children . In case of overdose, seek professional help or contact a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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