FDA label 437f9498-227c-5649-e063-6294a90acf61

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: 20ebce45-3a55-5e3d-e063-6394a90adc38
SPL ID: 437f9498-227c-5649-e063-6294a90acf61
Version: 3
Effective date: 2025-11-13
Source export date: 2026-10-12
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/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:27:02

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		437f9498-227c-5649-e063-6294a90acf61	id
spl set id		20ebce45-3a55-5e3d-e063-6394a90adc38	set_id

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 in urination due to enlargement of the prostate gland Ask a doctor of 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 consult a doctor if condition worsens or does not improve within 7 days bleeding occurs If pregnant or breastfeeding, ask a doctor before use. KEEP OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.