Home FDA labels 4debf365-33de-46eb-9bac-c417d88e5e5c FDA label 4debf365-33de-46eb-9bac-c417d88e5e5c 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 f1571895-1091-4c38-9fae-59a0f34381c7
SPL ID 4debf365-33de-46eb-9bac-c417d88e5e5c
Version 1
Effective date 2010-12-29
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 06:22:12 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: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use. Do not use if tamper evident seal is broken or missing.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.