Promethazine with codeine solution

Ingredients and appearance - Product information

Promethazine with codeine solution- Promethazine hydrochloride and codeine phosphate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-271
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Promethazine hydrochloride ( UNII: R61ZEH7I1I)( Promethazine - UNII: FF28EJQ494 ) 6.25 mgin 5 mL
Codeine phosphate ( UNII: GSL05Y1MN6)( Codeine anhydrous - UNII: UX6OWY2V7J ) 10 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Ascorbic acid ( UNII: PQ6CK8PD0R)
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 3 ( UNII: PN2ZH5LOQY)
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

Flavor GRAPE (grape blend flavor)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040650 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL( 63187-271), REPACK( 63187-271)