FDA label f7034d80-4b3a-4073-9539-ec38e1bc9684

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
7bb94254-2b3c-4a40-aa1d-68332597d980
SPL ID
f7034d80-4b3a-4073-9539-ec38e1bc9684
Version
3
Effective date
2012-01-19
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:41

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 using if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged 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 into the rectum by using fingers or an mechanical device or applicator. Stop use and ask a doctor if ■ bleeding occurs ■ condition worsens or does not improve within 7 days ■ an allergic reaction develops ■ the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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