AMOXI-TABS- amoxicillin tablet, film coated

Amoxi-Tabs by

Drug Labeling and Warnings

Amoxi-Tabs by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc., Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For use in dogs and cats

CAUTION

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

DESCRIPTION

Amoxi-Tabs (amoxicillin tablets) is a semisynthetic antibiotic with a broad spectrum of activity. It provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

CLINICAL PHARMACOLOGY

Amoxi-Tabs is stable in the presence of gastric acid and may be given without regard to meals. It is rapidly absorbed after oral administration. It diffuses readily into most body tissues and fluids with the exception of brain and spinal fluid, except when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine.

Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms. It acts through the inhibition of biosynthesis of cell wall mucopeptide. In vitro and/or in vivo studies have demonstrated the susceptibility of most strains of the following gram-positive and gram-negative bacteria: a- and b-haemolytic streptococci, nonpenicillinaseproducing staphylococci, Streptococcus faecalis, Escherichia coli, and Proteus mirabilis. Because it does not resist destruction by penicillinase, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. All strains of Pseudomonas and most strains of Klebsiella and Enterobacter are resistant.

INDICATIONS AND USAGE

Dogs: Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the following infections:

Respiratory tract infections (tonsillitis, tracheobronchitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis. Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

Gastrointestinal tract infections (bacterial gastroenteritis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis. Bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., and Proteus mirabilis.

Soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

Cats:Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the following infections:

Upper respiratory tract infections due to Staphylococcus aureus, Streptococcus spp., and E. coli.

Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.

Gastrointestinal tract infections due to E. coli. Skin and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Pasteurella multocida.

As with all antibiotics, appropriate in vitro culturing and susceptibility testing of samples taken before treatment should be conducted.

CONTRAINDICATIONS

The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

WARNING

For use in dogs and cats only.

ADVERSE REACTIONS

Amoxicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION:

Dogs: The recommended dosage is 5 mg/lb of body weight twice a day.

Cats: The recommended dosage is 50 mg (5–10 mg/lb) once a day.

Dosage should be continued for 5–7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy.

STORAGE AND HANDLING

Do Not Store at Temperatures Above 25°C (77°F)

Keep Bottle Tightly Closed.

HOW SUPPLIED

Amoxi-Tabs are supplied in 5 strengths: 50 mg, 100 mg, 150 mg, and 200 mg in bottles of 500 tablets; 400 mg in bottles of 250 tablets.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 055-078
Approved by FDA under NADA # 055-081

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

P1523357
Revised: January 2020

PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

INGREDIENTS AND APPEARANCE

AMOXI-TABS 
amoxicillin tablet, film coated

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 54771-8007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	150 mg

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	BMP208
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-8007-7	500 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA055078	02/04/1976

AMOXI-TABS 
amoxicillin tablet, film coated

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 54771-6044
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	200 mg

Product Characteristics
Color	ORANGE (Coral)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	BMP203
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-6044-4	500 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA055078	02/04/1976

AMOXI-TABS 
amoxicillin tablet, film coated

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 54771-6046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)	AMOXICILLIN ANHYDROUS	400 mg

Product Characteristics
Color	GREEN	Score	no score
Shape	ROUND	Size	14mm
Flavor		Imprint Code	BMP196
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-6046-6	250 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA055078	02/04/1976

Labeler - Zoetis Inc. (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917683	MANUFACTURE