FDA.reportPublic FDA data

PAI, Lactulose Solution USP

Manufacturer
TriRx Huntsville Pharmaceutical Services
Effective date
2024-12-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:46:48

Label at a glance#

ProductLactulose
Active ingredientLACTULOSE
Label structure14 sections

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

DescriptionDescription

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

Clinical PharmacologyClinical Pharmacology

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Contraindications

CONTRAINDICATIONS SECTION

ContraindicationsContraindications

Warnings

WARNINGS SECTION

WarningsWarnings

Precautions

PRECAUTIONS SECTION

PrecautionsPrecautions

Pregnancy

PREGNANCY SECTION

PregnancyPregnancy

Pediatric Use

PEDIATRIC USE SECTION

Pediatric UsePediatric Use

Adverse Reactions

ADVERSE REACTIONS SECTION

Adverse ReactionsAdverse Reactions

Overdosage

OVERDOSAGE SECTION

OverdosageOverdosage

Dosage Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

How Supplied

HOW SUPPLIED SECTION

How SuppliedHow Supplied

Label 16 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 16 ozLabel 16 oz

Label 32 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 32 ozLabel 32 oz

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80432-06880432-068-33, 80432-068-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SODIUM HYDROXIDE55X04QC32IIACT
LACTULOSE9U7D5QH5AEACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28ea292f-9847-397f-e063-6394a90af3cb28ea292f-9846-397f-e063-6394a90af3cb2024-12-10Warnings, Adverse reactionsExact identifier
spl id: 28ea292f-9847-397f-e063-6394a90af3cb
spl set id: 28ea292f-9846-397f-e063-6394a90af3cb

Reported adverse events (FAERS/openFDA)#

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