FDA.reportPublic FDA data

FDA label 17cecb0a-0c16-cdda-744e-a3dea9333e1e

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
a95c678f-84f7-13db-f5b5-05d4d8761fc4
SPL ID
17cecb0a-0c16-cdda-744e-a3dea9333e1e
Version
1
Effective date
2012-01-30
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:04

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 an enlarged prostate 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 use more than directed Stop use and ask a doctor if • symptoms get worse or do not get better in 7 days • bleeding occurs

Reported adverse events (FAERS/openFDA)#

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