FDA label 3fbd65ad-e359-471b-905f-2fc58cc96547

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
f5c51668-ba24-4d4d-a526-bd881c78f21a
SPL ID
3fbd65ad-e359-471b-905f-2fc58cc96547
Version
2
Effective date
2017-11-10
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:01:49

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 • diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are now taking a prescription drug for high blood pressure or depression When using this product do not use more than the recommended daily dosage Stop use and ask a doctor if • bleeding occurs • 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.