FDA label 92ede62f-582d-4d85-8999-b0ab74932af1

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: 61c90266-b2ba-4dae-9798-f70824dc0a07
SPL ID: 92ede62f-582d-4d85-8999-b0ab74932af1
Version: 1
Effective date: 2010-02-01
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:47:33

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		92ede62f-582d-4d85-8999-b0ab74932af1	id
spl set id		61c90266-b2ba-4dae-9798-f70824dc0a07	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. Ask a doctor before use if you have heart disease thyroid disease difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage. Stop use and ask a doctor if you experience bleeding condition worsens or does not improve within 7 days. These may be signs of a serious condition. If pregnant or breastfeeding 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.