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
2026-10-12
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/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:44

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.