CEFADROXIL

STAT Rx USA LLC
PSS World Medical 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 - CEFADROXIL - 500 mg CAPSULES

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

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
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Relabeling and Repackaging by

PACKAGE LABEL - CEFADROXIL - 500 mg CAPSULES

Rx only

CEFADROXIL CEFADROXIL CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:42549-504(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:42549-504-14 14 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065352 2007-01-25