FDA label 377fdab7-4298-b8c7-e063-6394a90a79b5

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: 37589041-7c55-7435-e063-6394a90afa1b
SPL ID: 377fdab7-4298-b8c7-e063-6394a90a79b5
Version: 2
Effective date: 2025-06-13
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:39:38

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		377fdab7-4298-b8c7-e063-6394a90a79b5	id
spl set id		37589041-7c55-7435-e063-6394a90afa1b	set_id

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 1. If symptoms worsen or do not improve within 7 days, seek medical advice. 2. Do not exceed the recommended daily dosage without a doctor's instruction. 3. Consult a doctor immediately if bleeding occurs. 4. Do not insert this product into the rectum using fingers or any applicator. 5. 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.