FDA label 48f99598-8bdc-cb9d-e063-6294a90a0407

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
ea090541-ab13-4ab0-9923-b97933b72766
SPL ID
48f99598-8bdc-cb9d-e063-6294a90a0407
Version
2
Effective date
2026-01-22
Source export date
2026-10-12
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/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:57:30

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 before use if you are presently taking a prescription drug for high blood pressure or depression When using this product do not use more than directed unless told to do so by a doctor do not put directly in the rectum by using fingers or mechanical device Stop use and ask doctor if rectal bleeding occurs condition worsens or does not improve within 7 days 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.