Home FDA labels 7d67400a-735c-4db9-e053-2a91aa0ae85b FDA label 7d67400a-735c-4db9-e053-2a91aa0ae85b 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 2e32bf60-06e2-4d62-8e62-480672b55701
SPL ID 7d67400a-735c-4db9-e053-2a91aa0ae85b
Version 2
Effective date 2018-12-19
Source export date 2026-09-28
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:25:15 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 Warnings: Use only as directed. Keep out of reach of children. Do not use on children under 5 years of age. If pregnant or breastfeeding, ask a doctor before use. This product does not treat sleep apnea. Stop use and ask a doctor if symptoms do not improve in 7 days.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.