PAI, Lactulose Solution USP

Lactulose by

Drug Labeling and Warnings

Lactulose by is a Prescription medication manufactured, distributed, or labeled by TriRx Huntsville Pharmaceutical Services. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LACTULOSE- lactulose liquid 
TriRx Huntsville Pharmaceutical Services

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PAI, Lactulose Solution USP

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Pregnancy

Pediatric Use

Adverse Reactions

Overdosage

Dosage Administration

How Supplied

Label 16 oz

Label 32 oz

LACTULOSE 
lactulose liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80432-068
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE)	LACTULOSE	10 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80432-068-33	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2024
2	NDC: 80432-068-35	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074623	12/10/2024

Labeler - TriRx Huntsville Pharmaceutical Services (117090286)

Revised: 12/2024

Document Id: 28ea292f-9847-397f-e063-6394a90af3cb

34391-3

Set id: 28ea292f-9846-397f-e063-6394a90af3cb

Version: 1

Effective Time: 20241210