FDA label 7db048a3-6556-41d8-a5fe-b75e462d266e

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
9e1f7343-17c7-45f8-963d-ba1a21d4b0f1
SPL ID
7db048a3-6556-41d8-a5fe-b75e462d266e
Version
1
Effective date
2010-12-06
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:51:42

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 Allergy alert: Certain persons can develop allergic reactions to ingredients in this product. 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 Stop use and ask a doctor if Rectal bleeding occurs Condition worsens or does not improve within 7 days Allergic reaction occurs Symptoms clear up and return within a few days Redness, irritation, swelling, pain or other symptoms begin or increase Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. 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. When using this product Do not put this product into the rectum by using fingers or any mechanical device or applicator Do not exceed the recommended daily dosage unless directed by a doctor

Reported adverse events (FAERS/openFDA)#

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