FDA.reportPublic FDA data

FDA label 5b68e907-94ad-450b-a11c-01f2f5d51d0e

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
ea431796-2870-4932-a4e3-fb63f962a5d4
SPL ID
5b68e907-94ad-450b-a11c-01f2f5d51d0e
Version
1
Effective date
2021-04-29
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 01:30:00

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 the child is on a sodium-restricted diet has kidney disease Ask a doctor before using any laxative if the child has: abdominal pain, nausea, or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week Stop use and consult a doctor if the child has rectal bleeding no bowel movement after the enema is given These symptoms may indicate a serious condition.

Reported adverse events (FAERS/openFDA)#

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