FDA.reportPublic FDA data

FDA label 37619408-1a58-4db4-9294-dae666cbff9a

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
dc6c176c-8982-4659-9af0-fe1a36085f0e
SPL ID
37619408-1a58-4db4-9294-dae666cbff9a
Version
8
Effective date
2021-12-16
Source export date
2026-11-06
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:54:00

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: ​​Do not use ​ if you have ever had an allergic reaction to this product or any of its ingredients. ​Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. ​Keep out of reach of children. ​ In case of overdose, get medical help or call a Poison Control Center right away. ​If pregnant or breast feeding, ​ ask a doctor before using product.​​ Store at room temperature. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Reported adverse events (FAERS/openFDA)#

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