FDA label 8e2597b3-2a81-4655-8748-264fd09f5718

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: 5e9f5fd9-2dca-4bce-8cb0-36cfb07b3967
SPL ID: 8e2597b3-2a81-4655-8748-264fd09f5718
Version: 2
Effective date: 2018-01-24
Source export date: 2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:48:02

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		8e2597b3-2a81-4655-8748-264fd09f5718	id
spl set id		5e9f5fd9-2dca-4bce-8cb0-36cfb07b3967	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

Warning For external use only. Using this product: Do not exceed the recommended daily dosage unless directed by a doctor. Do not insert into rectum or vagina using fingers or mechanical device. Stop use and ask doctor if: Rectal bleeding occurs, condition worsens or does not improve within 7 days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Reported adverse events (FAERS/openFDA)#

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