FDA label aa419e32-bd4b-4d3b-a0a3-193135b738cc

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
0a201d6d-0e45-43ca-8e09-e8b0e10ed2f4
SPL ID
aa419e32-bd4b-4d3b-a0a3-193135b738cc
Version
2
Effective date
2021-05-04
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:23

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. Ask a doctor before using this product if you are on a sodium-restricted diet have kidney disease are pregnant or nursing a baby Ask a doctor before using any laxative if you: have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks have already used a laxative for more than 1 week Stop using this product and consult a doctor if you have rectal bleeding have no bowel movement after the enema is given These symptoms may indicate a serious condition. Keep out of reach of children In case of overdose or accidental ingestion, get medical help right away.

Reported adverse events (FAERS/openFDA)#

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