FDA label ea85388c-b67d-4934-9c5a-c8453597b3b5

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: f8da3187-55d4-4e6f-a8ed-a0f76744e7ee
SPL ID: ea85388c-b67d-4934-9c5a-c8453597b3b5
Version: 2
Effective date: 2024-01-12
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 06:04:08

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		ea85388c-b67d-4934-9c5a-c8453597b3b5	id
spl set id		f8da3187-55d4-4e6f-a8ed-a0f76744e7ee	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 noticed a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if You have rectal bleeding. You fail to have a bowel movement after use. 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.