FDA label 8bc0e424-2449-41ef-9901-f9cb8a55be91

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: fc6dc813-717e-5e5c-4b72-9e46e40e9c40
SPL ID: 8bc0e424-2449-41ef-9901-f9cb8a55be91
Version: 3
Effective date: 2021-06-26
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:22:00

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		8bc0e424-2449-41ef-9901-f9cb8a55be91	id
spl set id		fc6dc813-717e-5e5c-4b72-9e46e40e9c40	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 rectal use only Do not use laxative products for a period longer than one week unless directed by a doctor Ask a doctor before use if you have • abdominal pain, nausea or vomiting • a sudden change in bowel habits that lasts longer than 2 weeks Stop use and ask a doctor if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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