FDA label aec252d6-282a-421e-a90d-39a5af3fdd8a

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
b387c743-063a-42d4-8ed7-530f60705dd2
SPL ID
aec252d6-282a-421e-a90d-39a5af3fdd8a
Version
2
Effective date
2017-11-20
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:19

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.