FDA.reportPublic FDA data

FDA label 959cee62-60f9-6277-e053-2a95a90ab5b9

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
cea38a9a-1f3e-4041-bfff-628e526bbd18
SPL ID
959cee62-60f9-6277-e053-2a95a90ab5b9
Version
2
Effective date
2019-10-23
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:52:51

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 For rectal use only May cause rectal discomfort or a burning sensation Ask a Doctor before using any laxative if child has abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than two weeks already used a laxative for more than 1 week Stop use and consult a doctor if child has rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition. 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.