FDA.reportPublic FDA data

FDA label 0d281d68-021f-675d-e063-6294a90a07dd

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
0d281d68-021e-675d-e063-6294a90a07dd
SPL ID
0d281d68-021f-675d-e063-6294a90a07dd
Version
1
Effective date
2023-12-23
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:31

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.