Home FDA labels 4d01b0ed-a87d-6ab8-e054-00144ff8d46c FDA label 4d01b0ed-a87d-6ab8-e054-00144ff8d46c 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 4721c950-005b-4f33-900e-26dd4ac03228
SPL ID 4d01b0ed-a87d-6ab8-e054-00144ff8d46c
Version 4
Effective date 2017-04-12
Source export date 2026-09-28
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:51:13 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 40 degrees C or 104 degrees F. Do not use if seal is broken.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.