LACTULOSE SOLUTION- lactulose solution solution 
TriRx Huntsville Pharmaceutical Services, LLC

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Lactulose Solution USP

Label Description

label Clinical Pharmacology

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

label indications and usage

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

Label Contraindications

label warnings

label 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

Label Adverse Reactions

label-overdoseLabel Overdose cont

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

Label-Dosage and Administration

label How Supplied

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LACTULOSE SOLUTION 
lactulose solution solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80432-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTULOSE (UNII: 9U7D5QH5AE) (LACTULOSE - UNII:9U7D5QH5AE) LACTULOSE10 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80432-001-33473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07599301/01/2020
Labeler - TriRx Huntsville Pharmaceutical Services, LLC (117090286)
Establishment
NameAddressID/FEIBusiness Operations
TriRx Huntsville Pharmaceutical Services, LLC117090286manufacture(80432-001)

Revised: 1/2023
Document Id: f1f0ab04-0096-9db4-e053-2995a90aa04c
Set id: b8434772-26c8-fce9-e053-2995a90abc7c
Version: 2
Effective Time: 20230110
 
TriRx Huntsville Pharmaceutical Services, LLC