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FDA Product

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

68788-8100

Regulatory Information

68788-8100

ANDA040649

C73584

September 12, 2023

USA

Promethazine DM Oral Solution

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

791119022

Active Ingredients

DEXTROMETHORPHAN HYDROBROMIDE

Quantity: 15 mg in 5 mL

Code: 9D2RTI9KYH

Class Code: ACTIB

PROMETHAZINE HYDROCHLORIDE

Quantity: 6.25 mg in 5 mL

Code: R61ZEH7I1I

Class Code: ACTIB

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ASCORBIC ACID

Code: PQ6CK8PD0R

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MENTHOL, UNSPECIFIED FORM

Code: L7T10EIP3A

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

Active Moieties

DEXTROMETHORPHAN

Code: 7355X3ROTS

PROMETHAZINE

Code: FF28EJQ494

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