FDA label d4330b29-1723-431d-9f26-9ab6bfd52003

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
efaef0be-61b3-4578-8788-8e0d18fae5ee
SPL ID
d4330b29-1723-431d-9f26-9ab6bfd52003
Version
1
Effective date
2010-02-22
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:01

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.