FDA label 503c5b9a-7e19-477e-94c0-61fac1324f2c

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: bb03e4f1-16f8-da04-1262-2eeecb19568e
SPL ID: 503c5b9a-7e19-477e-94c0-61fac1324f2c
Version: 5
Effective date: 2018-11-26
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 01:30:17

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		503c5b9a-7e19-477e-94c0-61fac1324f2c	id
spl set id		bb03e4f1-16f8-da04-1262-2eeecb19568e	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 when abdominal pain, nausea, or vomiting are present for more than one week unless directed by a doctor Ask a doctor before use if you are taking mineral oil have noticed a sudden change in bowel habits that last over 2 weeks Stop use and ask a doctor if you have no bowel movement after 3 daysyou have rectal bleedingThese could be signs of a serious condition If pregnant or breast-feeding, ask a health 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.