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
2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:06

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.