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FDA Approval

Acetaminophen and Codeine Phosphate

CompanyPhysicians Total Care, Inc. (DUNS: 194123980)

Effective Date

November 10, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Codeine(12 mg in 5 mL)

Acetaminophen(120 mg in 5 mL)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

Products (1)

Acetaminophen and Codeine Phosphate

NDC Product Code

54868-0378

Application Number

ANDA087508

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 10, 2010

Ingredients

Code: GSL05Y1MN6Class: ACTIBQuantity: 12 mg in 5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 120 mg in 5 mL

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

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