FDA label f225d923-b920-47af-9e83-66997ec1de6c

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
de14265c-cd0b-46a9-aa5b-81d77247a50d
SPL ID
f225d923-b920-47af-9e83-66997ec1de6c
Version
3
Effective date
2025-05-29
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:38:04

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 external use only 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 unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if ▪ bleeding occur ▪ condition gets worse or does not Improve within 7 days 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.