FDA.reportPublic FDA data

FDA label d629450d-92a8-4755-941e-e23aaede583d

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
5662fcac-ecdb-4229-abb7-50e48edb9ec9
SPL ID
d629450d-92a8-4755-941e-e23aaede583d
Version
4
Effective date
2016-08-25
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:49

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 this product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Store at room temperature.

Reported adverse events (FAERS/openFDA)#

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