FDA label 5a877b42-8cce-4c0a-a2ef-3324577ad4d2

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
1c704359-89a4-449c-961c-ad527cb467c2
SPL ID
5a877b42-8cce-4c0a-a2ef-3324577ad4d2
Version
1
Effective date
2014-03-11
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:56

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

Warning For rectal use only Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. 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 When using this product do not exceed recommended daily dose unless directed by a doctor in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly. 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.

Reported adverse events (FAERS/openFDA)#

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