FDA label 4048ff97-3acc-49b3-a785-ea2d24176123

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: 59305749-d5af-412f-93d9-c20ff73ca523
SPL ID: 4048ff97-3acc-49b3-a785-ea2d24176123
Version: 2
Effective date: 2016-02-23
Source export date: 2026-09-28
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/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:22:51

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		4048ff97-3acc-49b3-a785-ea2d24176123	id
spl set id		59305749-d5af-412f-93d9-c20ff73ca523	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: For external and/or intrarectal use only. Not for oral use. Avoid spicy or sour foods when using this product. If pregnant, please consult a health professional. Keep this and all drugs out of reach of children. Stop using and consult a doctor, if bleeding occurs, condition worsens or does not improve within 7 days. Introduction of applicator into the rectum causes additional pain.

Reported adverse events (FAERS/openFDA)#

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