FDA label ad96a386-e1f5-4ed7-b625-2e55ec101ee5

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
131aefdc-634f-476a-86d4-8deb78946b30
SPL ID
ad96a386-e1f5-4ed7-b625-2e55ec101ee5
Version
4
Effective date
2017-11-02
Source export date
2026-08-08
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/2026-08-08/ff6f8a7e8311a0dd3c947cd18ca343b8c43f8b6003d238bee8402e80a049f204/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:27:08

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)