Home FDA labels b60bc54e-a821-122b-e053-2995a90a588d FDA label b60bc54e-a821-122b-e053-2995a90a588d 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 c375df5f-186e-470a-88fd-eb07dd6314e6
SPL ID b60bc54e-a821-122b-e053-2995a90a588d
Version 4
Effective date 2020-12-09
Source export date 2026-09-28
Source partition 1
Source file https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:13:17 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.