Karbinal ER

Basic Information

Product Name

Karbinal ER

FDA Product Code

23594-101

Regulatory Information

NDC Product Code

23594-101

Application Number

NDA022556

Marketing Category

C73594

Effective Date

January 5, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use KARBINAL ER safely and effectively. See full prescribing information for KARBINAL ER. Karbinal ER (carbinoxamine maleate) extended-release oral suspension Initial U.S. Approval: 1953

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM METABISULFITE

Code: 4VON5FNS3C

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

HIGH FRUCTOSE CORN SYRUP

Code: XY6UN3QB6S

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

SODIUM POLYSTYRENE SULFONATE

Code: 1699G8679Z

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

CARBINOXAMINE MALEATE

Quantity: 4 mg in 5 mL

Code: 02O55696WH

Class Code: ACTIB

Active Moieties

CARBINOXAMINE

Code: 982A7M02H5

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

POLYSORBATE 80

SODIUM METABISULFITE

GLYCERIN

METHYLPARABEN

PROPYLPARABEN

XANTHAN GUM

SUCROSE

HIGH FRUCTOSE CORN SYRUP

POVIDONE

SODIUM POLYSTYRENE SULFONATE

ANHYDROUS CITRIC ACID

TRIACETIN

Active Moieties

CARBINOXAMINE