Home FDA labels b60b967b-f110-336b-e053-2a95a90acef5 FDA label b60b967b-f110-336b-e053-2a95a90acef5 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 194f58b8-a1a3-42c5-8942-83d08fa1c910
SPL ID b60b967b-f110-336b-e053-2a95a90acef5
Version 4
Effective date 2020-12-09
Source export date 2026-09-28
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:00:13 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 and cautions Warnings: KEEP OUT OF REACH OF CHILDREN . For professional use only. Do not swallow. Not recommended for use by children under 18 months of age. Store at room temperature. Do not expose to excessive heat over 104°F (40°C). Do not use if seal is broken.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.