Label: AMOXI-MAST- amoxicillin suspension

  • NDC Code(s): 0061-8128-01
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    LACTATING COW FORMULA
    (FÓRMULA PARA VACAS LACTANTES)

    Intramammary Infusion
    (Infusión intramamaria)

  • SPL UNCLASSIFIED SECTION

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

    Amoxi-Mast (amoxicillin intramammary infusion) is specially prepared for the treatment of bovine mastitis in lactating cows.

  • DESCRIPTION

    DESCRIPTION: Amoxi-Mast is a stable, nonirritating suspension of amoxicillin trihydrate containing the equivalent of 62.5 mg of amoxicillin per disposable syringe. Amoxi-Mast is manufactured by a nonsterilizing process.

    Amoxicillin trihydrate is a semisynthetic penicillin derived from the penicillin nucleus, 6-amino-penicillanic acid. Chemically, it is d(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

  • MECHANISM OF ACTION

    ACTION: Amoxicillin trihydrate is bactericidal in action against susceptible organisms. It is a broad-spectrum antibiotic which is effective against common infectious mastitis pathogens, namely Streptococcus agalactiae and penicillin-sensitive Staphylococcus aureus.

    In vitro studies have demonstrated the susceptibility of the following strains of bacteria: α- and β-haemolytic streptococci, nonpenicillinase-producing staphylococci, and Escherichia coli. Susceptibility has not been demonstrated against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Pseudomonas, Klebsiella, and Enterobacter are resistant. The clinical or subclinical significance of these in vitro studies is not known.

  • INDICATIONS & USAGE

    INDICATIONS: Amoxi-Mast is indicated in the treatment of subclinical infectious bovine mastitis in lactating cows due to Streptococcus agalactiae and penicillin-sensitive Staphylococcus aureus. Early detection and treatment of mastitis is advised.

  • WARNINGS

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    WARNINGS: Milk taken from animals during treatment and for 60 hours (5 milkings) after the last treatment must not be used for food. Treated animals must not be slaughtered for food purposes within 12 days after the last treatment.

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  • PRECAUTIONS

    PRECAUTION: Because it is a derivative of 6-amino-penicillanic acid, Amoxi-Mast has the potential for producing allergic reactions. Such reactions are rare; however, should they occur, the subject should be treated with the usual agents (antihistamines, pressor amines).

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy antiseptic. Dry thoroughly. Clean and disinfect the teat with alcohol swabs provided in the carton. Remove the syringe tip cover and insert the tip of the syringe into the teat orifice. Express the suspension into the quarter with gentle and continuous pressure. Withdraw the syringe and grasp the end of the teat firmly. Massage the medication up into the milk cistern.

    For optimum response, the drug should be administered by intramammary infusion in each infected quarter as described above. Treatment should be repeated at 12-hour intervals for a total of 3 doses. At the next routine milking after the last dose, the treated quarter should be milked out and the milk discarded.

    Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.

  • HOW SUPPLIED

    HOW SUPPLIED: Amoxi-Mast is supplied in cartons of 12 single-dose syringes with 12 alcohol swabs. Each 10-mL, disposable syringe contains amoxicillin trihydrate equivalent to 62.5 mg of amoxicillin activity.

    Do Not Store Above 24°C (75°F)

  • SPL UNCLASSIFIED SECTION

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    Approved by FDA under NADA # 055-100

    Manufactured by:
    G.C. Hanford Mfg. Co.
    Syracuse, NY 13201

    Copyright © 2022 Merck & Co., Inc.,
    Rahway, NJ, USA and its affiliates.
    All rights reserved.

    Rev 10/2022

    INS15427 04

  • PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

    Amoxi-Mast®
    (amoxicillin intramammary infusion)

    LACTATING COW FORMULA

    Intramammary Infusion

    short tip

    60-HOUR MILKOUT

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

    12 single-dose (10 mL),
    disposable syringes

    Approved by FDA under NADA # 055-100

    MERCK
    Animal Health

    PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton
  • INGREDIENTS AND APPEARANCE
    AMOXI-MAST 
    amoxicillin suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0061-8128
    Route of AdministrationINTRAMAMMARY
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Amoxicillin (UNII: 804826J2HU) (Amoxicillin Anhydrous - UNII:9EM05410Q9) Amoxicillin Anhydrous62.5 mg  in 10 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0061-8128-0112 in 1 CARTON
    110 mL in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA05510011/16/1984
    Labeler - Merck Sharp & Dohme Corp. (001317601)