FDA label e18a9340-1aa9-4ab5-b0a3-e97246584fa9

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
899ab5d0-b6cd-496f-91dc-f15429bbcf2c
SPL ID
e18a9340-1aa9-4ab5-b0a3-e97246584fa9
Version
1
Effective date
2018-10-22
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:04:24

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 urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are 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 rectum by using fingers or any mechanical device or applicator Stop use and ask a physician if bleeding occurs the condition worsens or does not improve within 7 days an allergic reaction develops the symptom being treated does not subside or redness, irritation, swelling, pain, or other symptoms develops, persists, or increase 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: 800-222-1222.

Reported adverse events (FAERS/openFDA)#

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