Basic Information
Promethazine Hydrochloride and Dextromethophan Hydrobromide
50383-803
Regulatory Information
50383-803
ANDA040027
C73584
November 11, 2022
USA
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION
HUMAN PRESCRIPTION DRUG LABEL
6
Company Information
117696873
Active Ingredients
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
ASCORBIC ACID
Code: PQ6CK8PD0R
Class Code: IACT
ANHYDROUS CITRIC ACID
Code: XF417D3PSL
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
SACCHARIN SODIUM
Code: SB8ZUX40TY
Class Code: IACT
TRISODIUM CITRATE DIHYDRATE
Code: B22547B95K
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
METHYLPARABEN
Code: A2I8C7HI9T
Class Code: IACT
PROPYLPARABEN
Code: Z8IX2SC1OH
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
SODIUM BENZOATE
Code: OJ245FE5EU
Class Code: IACT
Active Moieties
PROMETHAZINE
Code: FF28EJQ494
DEXTROMETHORPHAN
Code: 7355X3ROTS