Biomox Tablets

Generic Name: amoxicillin
Dosage Form: FOR ANIMAL USE ONLY

Biomox®
(amoxicillin)

Veterinary Tablets
For use in DOGS only.

Biomox Tablets Description

BIOMOX® (amoxicillin) is a broad-spectrum, semisynthetic antibiotic which provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Amoxicillin chemically is D-(-)a-amino-p-hydroxybenzyl penicillin trihydrate.

Inactive Ingredients:
Dibasic Calcium Phosphate Dihydrate, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

ACTION

Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial cell wall mucopeptides. Most strains of the following gram-positive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo nonpenicillinase-producing staphylococci, alpha- and beta-hemolytic streptococci, Streptococcus faecalis, Escherichia coli and Proteus mirabilis. Amoxicillin does not resist destruction by penicillinase; therefore, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Enterobacter and Klebsiella and all strains of Pseudomonas are resistant.

Amoxicillin may be given without regard to meals because it is stable in gastric acid. It is rapidly absorbed following oral administration and diffuses readily into most body fluids and tissues. It diffuses poorly into the brain and spinal fluid except when the meninges are inflamed. Most of the amoxicillin is excreted in the urine unchanged.

INDICATIONS

BIOMOX® (amoxicillin) tablets are indicated in the treatment of the following infections in dogs when caused by susceptible strains of organisms:

BACTERIAL DERMATITIS due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp. and E. coli.

SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus, Streptococcus spp., E. coli, Proteus mirabilis and Staphylococcus spp.

As it is true with all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.

Contraindications

Use of amoxicillin is contraindicated in animals with a history of an allergic reaction to penicillin.

Adverse Reactions

Amoxicillin is a semisynthetic penicillin and, therefore, has the potential for producing allergic reactions. Epinephrine and/or steroids should be administered if an allergic reaction occurs.

Warnings

For use in dogs only.

Precautions

Until adequate reproductive studies are accomplished, Biomox® (amoxicillin) tablets should not be used in pregnant or breeding animals.

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Biomox Tablets Dosage and Administration

The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

SUPPLY

Biomox® (amoxicillin) tablets are supplied in 50 mg, 100 mg and 200 mg concentrations in bottles of 500 and 1000 tablets.

Manufactured for:

Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161
1-800-338-3659

Printed in USA

Rev. -02

05/08

READ ACCOMPANYING LITERATURE BEFORE USE.

For use in DOGS only.

Recommended Dosage:
5 mg per pound of body weight twice a day.

Dosage should be continued for 5 - 7 days or 48 hours after all symptoms have subsided.

AM10A

AM11A

AM12A

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

NDC-051311-201-50

Virbac
ANIMAL HEALTH

BIOMOX®
(amoxicillin)

50 mg

Each tablet contains amoxicillin trihydrate
equivalent to 50 mg of amoxicillin.

CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

NADA # 65-492, Approved by FDA

500 Tablets

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

NDC-051311-203-50

Virbac
ANIMAL HEALTH

BIOMOX®
(amoxicillin)

100 mg

Each tablet contains amoxicillin trihydrate
equivalent to 100 mg of amoxicillin.

CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

NADA # 65-492, Approved by FDA

500 Tablets

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

NDC-051311-205-50

Virbac
ANIMAL HEALTH

BIOMOX®
(amoxicillin)

200 mg

Each tablet contains amoxicillin trihydrate
equivalent to 200 mg of amoxicillin.

CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.

NADA # 65-492, Approved by FDA

500 Tablets

BIOMOX 
amoxicillin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-201
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin (amoxicillin) amoxicillin 50 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-201-50 500 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-201-10 1000 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA065492 05/24/2010
BIOMOX 
amoxicillin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-203
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin (amoxicillin) amoxicillin 100 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-203-50 500 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-203-10 1000 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA065492 05/24/2010
BIOMOX 
amoxicillin tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-205
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin (amoxicillin) amoxicillin 200 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51311-205-50 500 TABLET (TABLET) in 1 BOTTLE
2 NDC:51311-205-10 1000 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA065492 05/24/2010
Labeler - Virbac AH, Inc. (131568396)
Establishment
Name Address ID/FEI Operations
Okasa PVT Ltd 915793457 MANUFACTURE
Revised: 06/2010
 
Virbac AH, Inc.
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