FDA label 11bc7139-9e7a-4ca0-89f8-6f8c662b2c52

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
cfb1d1d9-d45d-4ead-bd73-48456dcff3df
SPL ID
11bc7139-9e7a-4ca0-89f8-6f8c662b2c52
Version
1
Effective date
2011-07-01
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:02:55

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 - high blood pressure - thyroid disease - diabetes - difficulty in urination due to enlargement of the prostate gland _____________________________________________________ Ask a doctor or pharmacist before use if you are - presently taking a prescription drug for high blood pressure or depression ______________________________________________________ Stop use and ask a doctor if - bleeding occurs - condition gets worse or does not improve within 7 days ______________________________________________________ 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.