Label: AMOXI-TABS- amoxicillin tablet, film coated
- NDC Code(s): 54771-6042-2, 54771-6043-3
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 14, 2024
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- SPL UNCLASSIFIED SECTION
- CAUTION
- DESCRIPTION
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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, nonpenicillinase-producing 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
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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
- WARNING
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- STORAGE AND HANDLING
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
AMOXI-TABS
amoxicillin tablet, film coatedProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6042 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 50 mg Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code BMP193 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-6042-2 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055081 06/02/1978 AMOXI-TABS
amoxicillin tablet, film coatedProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6043 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 100 mg Product Characteristics Color blue Score no score Shape ROUND Size 9mm Flavor Imprint Code BMP202 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-6043-3 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055081 06/02/1978 Labeler - Zoetis Inc. (828851555)