Home FDA labels 58d63b61-0ba4-40a7-aaf6-8b244d331d00 FDA label 58d63b61-0ba4-40a7-aaf6-8b244d331d00 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 b53e5739-c9f6-44e4-8032-c2bf24fa8398
SPL ID 58d63b61-0ba4-40a7-aaf6-8b244d331d00
Version 5
Effective date 2016-02-16
Source export date 2026-11-06
Source partition 10
Source file https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run 20261108T063105Z
Imported at 2026-11-08 07:49:46
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, contact physician or Poison Control Center right away. If pregnant or breast-feeding, seek advice of a health professional before use. Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.