Promethazine dm solution

Ingredients and appearance - Product information

Promethazine dm solution- Dextromethorphan hydrobromide and promethazine hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-272
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 15 mgin 5 mL
Promethazine hydrochloride ( UNII: R61ZEH7I1I)( Promethazine - UNII: FF28EJQ494 ) 6.25 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Ascorbic acid ( UNII: PQ6CK8PD0R)
Citric acid monohydrate ( UNII: 2968PHW8QP)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Menthol, unspecified form ( UNII: L7T10EIP3A)
Methylparaben ( UNII: A2I8C7HI9T)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sucrose ( UNII: C151H8M554)

Product Characteristics

Color YELLOW (Clear-Yellow) Flavor ORANGE (Orange-Pineapple)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040649 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK( 63187-272), RELABEL( 63187-272)