FDA label 01f08c0b-3892-4b19-b264-b715cdbe5985

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
73b916eb-ee12-4873-8423-2c7e5d68787b
SPL ID
01f08c0b-3892-4b19-b264-b715cdbe5985
Version
2
Effective date
2012-02-06
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:34

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

Reported adverse events (FAERS/openFDA)#

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