FDA label 54242664-3db6-4c8b-b4b8-65d5be638cde

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: c79c6815-9ddb-4b40-8939-15f20ea7b7bc
SPL ID: 54242664-3db6-4c8b-b4b8-65d5be638cde
Version: 1
Effective date: 2010-02-22
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:00:21

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		54242664-3db6-4c8b-b4b8-65d5be638cde	id
spl set id		c79c6815-9ddb-4b40-8939-15f20ea7b7bc	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 Using more than one enema in 24 hours can be harmful. Do not use If you have abdominal pain, nausea, or vomiting, unless directed by a doctor. Longer than one week unless directed by a doctor. More than one enema per day unless directed by a doctor. Consult a doctor before use if you have noticed a sudden change in bowel habits that persist over a period of 2 weeks if you have rectal bleeding or failure to have a bowel movement after use of a laxative. This may indicate a serious condition. if you are pregnant or nursing a baby Keep out of reach of children In case of accidental injestion or overdose, 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.