LACTULOSE SOLUTION solution

Lactulose Solution by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

CLINICAL PHARMACOLOGY

These highlights do not include all the information needed to use. See full prescribing information for Lactulose Initial U.S. approval

These Highlights do not include all the information needed to use. See full prescribing information for Lactulose Intial U.S. Approval

WARNINGS

PRECAUTIONS

These highlights do not include all the information needed to use. See full prescribing information for Lactulose Initial U.S. Approval. To report suspected adverse reactions contact lannet Company Inc at 1-800-332-1088

OVERDOSAGE

These highlights do not include all the information needed to use. See full prescribing information for Lactulose Initial U.S. Approval

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LACTULOSE SOLUTION 
lactulose solution solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80432-001
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80432-001-33	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075993	01/01/2020

Labeler - TriRx Huntsville Pharmaceutical Services, LLC (117090286)

Establishment
Name	Address	ID/FEI	Business Operations
TriRx Huntsville Pharmaceutical Services, LLC		117090286	manufacture(80432-001)