FDA label 80d920c4-0757-439e-b0c2-cbbe81109f77

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
c069d188-5a79-4885-835b-afb69eaf8a48
SPL ID
80d920c4-0757-439e-b0c2-cbbe81109f77
Version
11
Effective date
2019-11-11
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 02:07:55

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

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 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 • an ulcer • a bleeding problem • bloody or black stool 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

Reported adverse events (FAERS/openFDA)#

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