MedPath
FDA Approval

Promethazine VC With Codeine

October 7, 2011

HUMAN PRESCRIPTION DRUG LABEL

Codeine(10 mg in 5 mL)
Promethazine(6.5 mg in 5 mL)
Phenylephrine(5 mg in 5 mL)

Manufacturing Establishments (1)

Dispensing Solutions, Inc.

Dispensing Solutions, Inc.

066070785

Products (1)

Promethazine VC With Codeine

55045-1266

ANDA040660

ANDA (C73584)

ORAL

October 7, 2011

ALCOHOLInactive
Code: 3K9958V90MClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MENTHOLInactive
Code: L7T10EIP3AClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
CodeineActive
Code: GSL05Y1MN6Class: ACTIBQuantity: 10 mg in 5 mL
Code: R61ZEH7I1IClass: ACTIBQuantity: 6.5 mg in 5 mL
Code: 04JA59TNSJClass: ACTIBQuantity: 5 mg in 5 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
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