FDA label e423582a-d8b4-4815-9767-7782ce3dbdcd

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
fe7e75c8-0b9d-4bf6-a81f-d454ce479052
SPL ID
e423582a-d8b4-4815-9767-7782ce3dbdcd
Version
2
Effective date
2018-07-19
Source export date
2026-09-28
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/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:31:11

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. Do not use • more than one per day • for a period of longer than one week unless directed by a doctor • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor • if seal under product lid is damaged, missing or broken. Ask a doctor before use • if you have noticed a sudden change in bowel habits that persist over a period of two weeks • if you are pregnant or nursing a baby Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using a laxative. This 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.