FDA label a78bd90b-68ba-4e55-90fa-683f377f0295

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: a42b62b3-3b0a-4c11-96b3-8635e8c20ae2
SPL ID: a78bd90b-68ba-4e55-90fa-683f377f0295
Version: 4
Effective date: 2016-01-07
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:59:07

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		a78bd90b-68ba-4e55-90fa-683f377f0295	id
spl set id		a42b62b3-3b0a-4c11-96b3-8635e8c20ae2	set_id

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 when abdominal pain, nausea, or vomiting are present. Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period of 2 weeks. When using this product you may experience. rectal burning. mild cramps.abdominal discomfort. faintness. stop use and ask a doctor if you have rectal bleeding. you fill to have a bowel movement after using a laxative. These may be signs of a serious condition. you need to use a laxative for more than one week. 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.