Cefadroxil

PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.

cefadroxil capsules, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• CEFADROXIL DESCRIPTION
• CLINICAL PHARMACOLOGY
• CEFADROXIL INDICATIONS AND USAGE
• CEFADROXIL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for Patients
  • Drug/Laboratory Test Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• CEFADROXIL ADVERSE REACTIONS
• OVERDOSAGE
• CEFADROXIL DOSAGE AND ADMINISTRATION
  • Renal Impairment
• HOW SUPPLIED
• REFERENCES
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (50 Capsule Bottle)

FULL PRESCRIBING INFORMATION

CEFADROXIL DESCRIPTION

      Cefadroxil capsules contain the following inactive ingredients: Lactose monohydrate, magnesium stearate, FD&C Blue No.1, D&C Red No.28, FD&C Red No. 40, titanium dioxide, gelatin, sodium lauryl sulphate, and edible black ink (black iron oxide).

CLINICAL PHARMACOLOGY

CEFADROXIL INDICATIONS AND USAGE

CEFADROXIL CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Information for Patients

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

CEFADROXIL ADVERSE REACTIONS

OVERDOSAGE

CEFADROXIL DOSAGE AND ADMINISTRATION

Renal Impairment

HOW SUPPLIED

              
            

Store at

REFERENCES

• National Committee for Clinical Laboratory Standards, Approved Standard, Performance Standards for Antimicrobial Disk Susceptibility Test, 4^th Edition. Vol. 10 (7): M2-A4, Villanova, PA, April, 1990.
• National Committee for Clinical Laboratory Standards, Approved Standard: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 2nd Edition, Vol. 10(8): M7-A2, Villanova, PA, April, 1990.

GREENSTONE^® BRAND
Distributed by:
Greenstone LLC

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (50 Capsule Bottle)

GREENSTONE^® BRAND
cefadroxil capsules, USP
500 mg
Rx only

Cefadroxil Cefadroxil CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:55289-405(NDC:59762-2000) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFADROXIL CEFADROXIL 500 mg Inactive Ingredients Ingredient Name Strength lactose monohydrate MAGNESIUM STEARATE FD&C BLUE NO. 1 D&C RED NO. 28 FD&C RED NO. 40 titanium dioxide GELATIN SODIUM LAURYL SULFATE FERROSOFERRIC OXIDE Product Characteristics Color Size Imprint Code Shape WHITE (White Opaque) 21 mm C;97 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55289-405-10 10 in 1 BOTTLE, PLASTIC 2 NDC:55289-405-14 14 in 1 BOTTLE, PLASTIC 3 NDC:55289-405-20 20 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065352 2007-01-25