Home FDA labels 8ad67f0e-55d6-46ad-892a-5a0ea55a6a57 FDA label 8ad67f0e-55d6-46ad-892a-5a0ea55a6a57 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 eccb7f1b-a65a-483c-be10-71747dfe9363
SPL ID 8ad67f0e-55d6-46ad-892a-5a0ea55a6a57
Version 1
Effective date 2012-11-14
Source export date 2026-10-12
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:50:21 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 Do not use if outer package seal is broken. Stop use and consult a doctor if symptoms do not improve within 3 days or are accompanied by a fever. Not intended as a substitute for sleep. Consult a doctor before use in children younger than 8 years of age.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.