FDA label d4b0c77c-9a3d-4bae-b4f9-bf6defbdc796

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: 99ea8898-b1d4-4d98-afd2-81ad430c5792
SPL ID: d4b0c77c-9a3d-4bae-b4f9-bf6defbdc796
Version: 1
Effective date: 2010-02-22
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:41:53

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		d4b0c77c-9a3d-4bae-b4f9-bf6defbdc796	id
spl set id		99ea8898-b1d4-4d98-afd2-81ad430c5792	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. May cause rectal discomfort or a burning sensation. Do not use more than one per day for a period of longer than one week unless directed by a doctor laxative products when abdominal pain, nausea, or vominting are present unless directed by a doctor if seal under product lid is damaged, missing or broken. Ask a doctor before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks if you are pregnant or nursing a baby Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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