FDA label 01001e98-f563-4ee1-9f2a-ee47b1e9d714

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
db7520d8-9364-4d7a-ba81-79a2fc2fa40e
SPL ID
01001e98-f563-4ee1-9f2a-ee47b1e9d714
Version
12
Effective date
2024-03-15
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:39:04

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. For rectal use only. Do not use for more than 3 days if you have kidney disease if you have heart problems if you are dehydrated when abdominal pain, nausea, or vomiting are present unless directed by a doctor Ask a doctor before using this product if you: are 55 years of age or older are on a sodium-restricted diet have a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week Stop use and ask a doctor if you have rectal bleeding no bowel movement or no liquid comes out of the rectum after 30 minutes symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal] These symptoms may indicate a serious condition.

Reported adverse events (FAERS/openFDA)#

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