Amoxi-Mast

Manufacturer
Merck Sharp & Dohme Corp.
Effective date
2024-11-13
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:43:51

Label at a glance#

ProductAmoxi-Mast
Active ingredientAMOXICILLIN
Label structure11 sections

Label contents#

Full prescribing information#

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 SECTION

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 SECTION

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 SECTION

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 SECTION

WARNINGS SECTIONWARNINGS SECTION

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.

WARNINGS SECTIONWARNINGS SECTION

PRECAUTIONS SECTION

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 SECTION

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 SECTION

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.

STORAGE AND HANDLING SECTION

Do Not Store Above 24°C (75°F)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-8128-01Amoxi-Mast12 in 1 CARTONSUSPENSION126
0061-8128-01Amoxi-Mast10 mL in 1 SYRINGESUSPENSION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-8128AMOXI-MAST (AMOXICILLIN) SUSPENSION [MERCK SHARP & DOHME CORP.]62 package rows20241115_25fc3b5a-c0fd-47fb-b7a5-ba8fdc89a24c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AmoxicillinACTIVE INGREDIENT804826J2HU1
Amoxicillin AnhydrousACTIVE MOIETY9EM05410Q91

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0061-81280061-8128-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMOXICILLIN804826J2HUACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 11 · 216 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOXICILLINAMOXICILLINREMEDYREPACK INC.4adc198e-39d8-4b3e-bfa4-278aaf4064ae2026-09-09Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.b6ea2f81-aee6-4c88-b681-50eb28e80a862026-09-03Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINRedpharm Drug5a79669f-52f7-e8ea-e063-6394a90a93b82026-09-02Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.f37eb415-77b2-41b0-8d20-64e821e4b05d2026-09-02Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AMOXICILLINAMOXICILLINRedpharm Drug5a660370-9a81-33f9-e063-6394a90a6c622026-09-01Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINSportpharm LLCc4d4aeca-f63c-4548-a9b7-7f627e8fd45c2026-08-29Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.82c0c5d1-df2d-4352-bd12-99f955af569e2026-08-20Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.3a4afd36-dffa-44a1-9d09-e93cf66053bf2026-08-20Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINA-S Medication Solutions452eb254-028a-4e02-9cb0-85483a4abaf52026-08-10Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.afb4149a-0714-4a85-b9e8-2379a8e6a3022026-08-06Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINCoupler LLC5827b6de-6b48-d73a-e063-6394a90a4a722026-08-03Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8cb987bf-d45a-c15a-e053-2995a90aad462026-08-03Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINRedpharm Drug57f5652d-ee50-eb7e-e063-6394a90a7b662026-08-01Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINRedpharm Drug57e56202-950b-10f6-e063-6394a90a49122026-07-31Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.102c62ca-da20-4866-84a8-e3513824af4a2026-07-21Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINHAWAII REPACK, INC.bf130964-8386-4ab7-8d3b-fb0174670afc2026-07-17Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.18a4f555-a537-4c40-9bb2-dc3bd782fa272026-07-17Warnings, Adverse reactionsName fallback
generic name: AMOXICILLIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.