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
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