FDA label f7ae9422-b555-4569-8fdf-627b5a9ced45

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
9f180c73-181e-4cb2-8f77-8e9a6a1beed3
SPL ID
f7ae9422-b555-4569-8fdf-627b5a9ced45
Version
2
Effective date
2017-11-21
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 01:29:56

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 Dosage warning: Using more than one enema in 24 hours can be harmful. Do not use • if you are on a low salt diet • when abdominal pain, nausea or vomiting are present • for longer than one week • in patients with megacolon (as hypernatremic dehydration may occur) Ask a doctor before use if you have • kidney disease or impaired renal function • noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed. Serious side effects may occur from excess dosage. Stop use and ask a doctor if • symptoms last more than 2 weeks • you have rectal bleeding or fail to have a bowel movement after using this product These may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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.