FDA label d47d90ed-35a0-47c2-b164-f6ec9f71ab32

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
f311c9f0-d1b1-49dc-867f-cf5eb5d15b2a
SPL ID
d47d90ed-35a0-47c2-b164-f6ec9f71ab32
Version
1
Effective date
2018-10-25
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 02:41:21

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 Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. 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 unless directed by a doctor Stop use and ask a physician if bleeding occurs condition worsens or does not improve within 7 days introduction of applicator into 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 or contact a Poison Control Center right away: 800-222-1222.

Reported adverse events (FAERS/openFDA)#

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