Home FDA labels 559c93c2-a949-4fd9-98cb-7bb570c6de0e FDA label 559c93c2-a949-4fd9-98cb-7bb570c6de0e 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 d3e9dd7f-4183-4063-bd04-5fdc55e0ebfe
SPL ID 559c93c2-a949-4fd9-98cb-7bb570c6de0e
Version 1
Effective date 2012-09-10
Source export date 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:49:30 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 For external and/or intrarectal use only If condition worsens or does not improve within 7 days, consult a physician Do not exceed the recommended daily dosage unless directed by a doctor In case of bleeding, consult a physican promptly
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.