Home FDA labels d309a095-4290-4761-941f-dc68ad83d3bb FDA label d309a095-4290-4761-941f-dc68ad83d3bb 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 1200e9f8-4a5b-46d5-a96b-ce02af34c00a
SPL ID d309a095-4290-4761-941f-dc68ad83d3bb
Version 4
Effective date 2021-12-28
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 06:22:48 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: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional. KEEP OUT OF REACH OF CHILDREN.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.