FDA label 12d5a39f-b77f-446c-9c05-9c5922432a30

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: c74cd4d0-4574-49fe-a685-ed434d53a576
SPL ID: 12d5a39f-b77f-446c-9c05-9c5922432a30
Version: 2
Effective date: 2018-12-20
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:29:57

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		12d5a39f-b77f-446c-9c05-9c5922432a30	id
spl set id		c74cd4d0-4574-49fe-a685-ed434d53a576	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 use if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea or vomiting are present for longer than one week unless directed by a doctor Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after use If pregnant or breastfeeding ask a health care professional before use. Keep out of reach of children. In case of overdose, 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.