FDA.reportPublic FDA data

FDA label 0d27b90a-bd72-c1f5-e063-6394a90a22a0

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
0d27b90a-bd71-c1f5-e063-6394a90a22a0
SPL ID
0d27b90a-bd72-c1f5-e063-6394a90a22a0
Version
1
Effective date
2023-12-23
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:09:13

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 lf symptoms worsen or do notimprove within 7 days, seek medicaadvice. Do not exceed the recommendeodaily dosage without doctor's instruction. Consult a doctor immediately if bleeding occurs. Do not insert this product into the rectum using fingers or any applicator. Some people may be allergic to the ingredients.Discontinue use and consult a doctor if symptoms persist or worsen,including redness, irritation, swelling, or pain. Note: Discontinue use and consult a doctor if symptoms persist or worsen, including redness, irritation. swelling, or pain due to possible allergies to product ingredients

Reported adverse events (FAERS/openFDA)#

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