FDA label d3cf0652-d915-4d32-8f38-dc3df1283b2e

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
7983ad30-ee7f-49dc-8ffa-1457d21e590e
SPL ID
d3cf0652-d915-4d32-8f38-dc3df1283b2e
Version
2
Effective date
2012-07-18
Source export date
2026-11-06
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:43:20

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. Ask a doctor before using if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland Ask a doctor of 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 unless directed by a doctor Stop use and ask a doctor if ■ bleeding occurs ■ condition worsens or does not improve within 7 days ■ introduction of the applicator into the rectum causes additional pain. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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