FDA label 95b7740d-99bb-4dda-910a-0a1e95d62e17

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
21744505-0fbc-4e74-bd8f-e1ae5e322f9f
SPL ID
95b7740d-99bb-4dda-910a-0a1e95d62e17
Version
1
Effective date
2011-07-01
Source export date
2026-11-06
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:44:13

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 enlargement of the prostate gland _____________________________________________________ Ask a doctor or pharmacist before use if you are - presently taking a prescription drug for high blood pressure or depression ______________________________________________________ Stop use and ask a doctor if - bleeding occurs - condition gets worse or does not improve within 7 days ______________________________________________________ If pregnant or breastfeeding, 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.