FDA label a4d0d0be-1cb7-47a2-a6aa-75d93dea7545

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
11560597-3b0e-423c-a222-b20bbd98aae9
SPL ID
a4d0d0be-1cb7-47a2-a6aa-75d93dea7545
Version
1
Effective date
2010-11-18
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:10

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 use only. Ask a doctor before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate gland Ask a doctor before use if you have - heart disease - high blood pressure - diabetes - thyroid disease - trouble urinating due to an enlarged prostate gland 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 - do not put into rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if - bleeding occurs - condition worsens or does not improve within 7 days If pregnant or breast feeding, ask a health professional before use. Keep out of the 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.