FDA.reportPublic FDA data

FDA label 7c4cd754-468d-6cdb-e053-2991aa0a2123

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
8e8b719d-3f94-464b-b2a3-af4dd35c5cc1
SPL ID
7c4cd754-468d-6cdb-e053-2991aa0a2123
Version
5
Effective date
2018-12-05
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:59

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 burning sensation Ask a Doctor before using any laxative if you have 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 you have rectal bleeding no bowel movement after using 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.