FDA label 3612e48d-1a7f-44b4-9fb8-d33a35332dd0

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: 2c4185b0-405c-4937-b52a-f9c0230e1c9d
SPL ID: 3612e48d-1a7f-44b4-9fb8-d33a35332dd0
Version: 5
Effective date: 2017-06-16
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:37:19

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		3612e48d-1a7f-44b4-9fb8-d33a35332dd0	id
spl set id		2c4185b0-405c-4937-b52a-f9c0230e1c9d	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 Ask a doctor before use if you have nausea, vomiting, abdominal pain, or sudden change in bowel habits that persist over a period of 2 weeks When using this product do not use for more than 7 days unless directed by a doctor Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occurs after the use of a laxative. These could be signs of a serious condition. This product is intended 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.