FDA label ec8baea0-4012-4619-bb68-91cc10cd2fda

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
fe25bc32-e37a-45ab-887c-f0332b6cf990
SPL ID
ec8baea0-4012-4619-bb68-91cc10cd2fda
Version
1
Effective date
2016-10-25
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:01

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 Difficulty urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are 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 into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if Bleeding occurs the condition worsens or does not improve within 7 days An allergic reaction develops The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase 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.