FDA label 462d797b-d5de-e145-e063-6394a90a74d0

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: f4d26053-32aa-4cc9-8460-556acc38fe33
SPL ID: 462d797b-d5de-e145-e063-6394a90a74d0
Version: 5
Effective date: 2025-12-17
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:38:28

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		462d797b-d5de-e145-e063-6394a90a74d0	id
spl set id		f4d26053-32aa-4cc9-8460-556acc38fe33	set_id

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: Use only as directed. Keep this out of reach of children . Do not use on children under 5 years of age. If pregnant or breastfeeding, ask a physician before use. This product does not treat sleep apnea. For sleep apnea, consult with a specialist. If symptoms worsen after 14 days, discontinue use and ask a physician for help.

Reported adverse events (FAERS/openFDA)#

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