Home FDA labels 6cc3a007-fa56-7e6c-e053-2a91aa0ab251 FDA label 6cc3a007-fa56-7e6c-e053-2a91aa0ab251 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 9453f2da-3335-4383-af66-0598ce6af817
SPL ID 6cc3a007-fa56-7e6c-e053-2a91aa0ab251
Version 6
Effective date 2013-06-20
Source export date 2026-09-28
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:28:53 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
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 Stop use and ask doctor if symptoms of alcoholism persist. Do not use if you have an allergy or hypersensitivity to components of the formula. Not for Pediatric use. If pregnant or breast feeding ask a health professional before use. Keep out of the reach of children.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.