FDA.reportPublic FDA data

FDA label e0b77e11-7410-424e-b523-50fae75249a7

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
47e6d69c-1fa7-47c3-aa18-f6d1618353bc
SPL ID
e0b77e11-7410-424e-b523-50fae75249a7
Version
4
Effective date
2021-07-02
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:49

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 Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor before use if your child has • stomach pain • nausea • vomiting • a sudden change in bowel habits that lasts over 2 weeks When using this product your child may have rectal discomfort or a burning sensation Stop use and ask a doctor if your child has rectal bleeding or fails to have a bowel movement after use of a laxative. These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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