FDA label da57b311-87e7-4b20-e053-2a95a90a632c

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
0666d58a-2805-06e5-e054-00144ff88e88
SPL ID
da57b311-87e7-4b20-e053-2a95a90a632c
Version
10
Effective date
2022-03-16
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:36:00

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 bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis 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 When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. If pregnant or breast-feeding , ask a health professional before use. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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