FDA label a9aebbab-7bd2-42dd-932b-6f5c8aebd8e0

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
d6ab3693-7534-4d3c-a1b9-909d71df0bde
SPL ID
a9aebbab-7bd2-42dd-932b-6f5c8aebd8e0
Version
2
Effective date
2020-04-15
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:16:09

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 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 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 (1-800-222-1222).