FDA label ca1699d3-617b-4b76-a3cd-5955b6efd574

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: dbe65579-31fa-4d35-9ee2-3afb9fd5d119
SPL ID: ca1699d3-617b-4b76-a3cd-5955b6efd574
Version: 1
Effective date: 2010-02-22
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 06:01:36

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		ca1699d3-617b-4b76-a3cd-5955b6efd574	id
spl set id		dbe65579-31fa-4d35-9ee2-3afb9fd5d119	set_id

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 rectal use only. When using this product do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask a doctor in case of bleeding if condition worsens or does not improve within 7 days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.