FDA label fc6152a2-7161-250f-e053-6394a90a951a

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: 8d1e7ebe-b702-2343-e053-2995a90ac66a
SPL ID: fc6152a2-7161-250f-e053-6394a90a951a
Version: 3
Effective date: 2023-05-23
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:45:10

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		fc6152a2-7161-250f-e053-6394a90a951a	id
spl set id		8d1e7ebe-b702-2343-e053-2995a90ac66a	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 doctor brfore use if you have Heart Disease Thyroid Disease Diabetes Difficulty urinating due to an enlarged prostate gland Ask doctor before use if you are presently taking a prescription 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

Reported adverse events (FAERS/openFDA)#

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