FDA label eac92616-5273-4e9b-8040-6c22da0cde2d

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
229baa82-3c27-4470-b13a-ee3df63839c5
SPL ID
eac92616-5273-4e9b-8040-6c22da0cde2d
Version
3
Effective date
2019-12-20
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:21

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: 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 • If you have an ulcer or bleeding problem Ask a doctor before use if you have • Fever • Mucus in the stool Ask a doctor or pharmacist before use if you are • taking any drug 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 the ears 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 right away.

Reported adverse events (FAERS/openFDA)#

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