FDA label a8c1f436-e5de-0cc0-e053-2a95a90a2d16

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: a8c1f436-e5dd-0cc0-e053-2a95a90a2d16
SPL ID: a8c1f436-e5de-0cc0-e053-2a95a90a2d16
Version: 1
Effective date: 2020-06-23
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 05:39:31

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		a8c1f436-e5de-0cc0-e053-2a95a90a2d16	id
spl set id		a8c1f436-e5dd-0cc0-e053-2a95a90a2d16	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 Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives. Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

Reported adverse events (FAERS/openFDA)#

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