Home FDA labels 040bfcf7-f512-2fa1-e063-6394a90a5ef9 FDA label 040bfcf7-f512-2fa1-e063-6394a90a5ef9 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 040bfcf7-f511-2fa1-e063-6394a90a5ef9
SPL ID 040bfcf7-f512-2fa1-e063-6394a90a5ef9
Version 1
Effective date 2023-08-29
Source export date 2026-09-28
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:53:23 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.
Boxed warning cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Boxed warning sections page 1 of 1 · 1 matching rows.
boxed warning Warnings: Do not use: 1. as a substitute for sleep. This product is intended for occasional use only. 2. in children under 12 years of age. 3. If pregnant or breastfeeding, consult a healthcare professional before use. 4. Keep out of reach of children. In case of overdose, seek immediate medical attention or contact a poison control center. 5. Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.
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 Instructions on box Do not Use as a substitute for sleep. This product is intended for accosional use only in children under 12 years of age
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.