FDA label 285e1d5e-bebe-4993-8c5b-d6529c2db32f

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
1888cd0d-38fb-49cc-8c10-6dab3cf82ef2
SPL ID
285e1d5e-bebe-4993-8c5b-d6529c2db32f
Version
2
Effective date
2018-10-19
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:08:06

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 • diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland Ask a doctor or 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 • do not put this product into the rectum by using fingers or any mechanical device or applicator 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.