Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Basic Information

Product Name

FDA Product Code

42192-607

Regulatory Information

NDC Product Code

42192-607

Application Number

ANDA203375

Marketing Category

C73584

Effective Date

October 10, 2023

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

SUCRALOSE

Code: 96K6UQ3ZD4

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BROMPHENIRAMINE MALEATE

Quantity: 2 mg in 5 mL

Code: IXA7C9ZN03

Class Code: ACTIB

PSEUDOEPHEDRINE HYDROCHLORIDE

Quantity: 30 mg in 5 mL

Code: 6V9V2RYJ8N

Class Code: ACTIB

DEXTROMETHORPHAN HYDROBROMIDE

Quantity: 10 mg in 5 mL

Code: 9D2RTI9KYH

Class Code: ACTIB

Active Moieties