FDA label a3ce40a5-68c2-425a-a0fb-bb18e87673ef

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
1f560b71-24b8-4e94-96c7-dc70493a8648
SPL ID
a3ce40a5-68c2-425a-a0fb-bb18e87673ef
Version
3
Effective date
2017-10-23
Source export date
2026-09-28
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/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:41:26

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 DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN For rectal use only. Do not use when abdominal pain, nausea or vomiting are present. Ask a doctor before use if you have stomach pain, nausea or vomiting or have noticed a sudden change in bowel habits that lasts more than 2 weeks. Ask a doctor or pharmacist before use if you are taking any other drugs.. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product you may have abdominal discomfort, faintness, rectal burning, and mild cramps. Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition or if you need to use a laxative for more than one week. This package is for institutional use only. If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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