FDA label a3d95773-5f38-4f79-e053-2a95a90a131d

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
a3d95773-5f37-4f79-e053-2a95a90a131d
SPL ID
a3d95773-5f38-4f79-e053-2a95a90a131d
Version
1
Effective date
2020-04-21
Source export date
2026-11-06
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:52:57

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 and cautions

Warning Section (Carton AU) Medication may cause drowsiness. Do not drive a vehicle or operate machinery. Do not overdose - avoid alcohol. If an overdoes is taken see your health professional. If in doubt, contact a Poisons Information Centre (13 11 26) or a doctor. Carton Warning Section

Reported adverse events (FAERS/openFDA)#

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