FDA label e689b391-db60-4f6e-83fc-64c317e63ecf

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
f19d1124-59be-44a1-83d5-3cff6d8ad1fe
SPL ID
e689b391-db60-4f6e-83fc-64c317e63ecf
Version
2
Effective date
2021-04-28
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:00:55

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. 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.