FDA label a071df71-02f8-4a64-8325-937ec1caf4f2

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
665dd18d-0ff2-45d1-a3b8-e5bf18dce008
SPL ID
a071df71-02f8-4a64-8325-937ec1caf4f2
Version
1
Effective date
2009-11-05
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 01:29:29

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 in children under 2 years of age. Do not use if you have kidney disease, or are dehydrated, or for more than 3 days without asking a doctor. you have abdominal pain, nausea, or vomiting as directed by a doctor. you are on a low salt diet unless directed by a doctor. Do not use in children under two years of age. Ask a doctor before use if you have noticed a sudden change in bowel habits that persists 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. Stop use and consult a doctor if you have noticed a sudden change in bowel habits that persists 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 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.