Approved by FDA under NADA # 065-492 BIOMOX ® (amoxicillin tablets)

Manufacturer
Virbac AH, Inc.
Effective date
2024-08-26
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 02:43:27

Label at a glance#

ProductBiomox
Active ingredientamoxicillin
Label structure14 sections

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For use in DOGS only.

DESCRIPTION:

DESCRIPTION SECTION

BIOMOX® (amoxicillin tablets) are 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-(-)α-amino-p-hydroxybenzyl penicillin trihydrate.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

ACTION:

CLINICAL PHARMACOLOGY SECTION

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, Enterococcus 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:

VETERINARY INDICATIONS SECTION

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

BACTERIAL DERMATITIS due to Staphylococcus aureus, Strepto-coccus spp., Staphylococcus spp., and Escherichia coli.

SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus,Enterococcus faecalis, Escherichia coli, Proteus mirabilis, and Staphylococcus spp.

With all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

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

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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:

WARNINGS SECTION

For use in dogs only.

PRECAUTIONS:

PRECAUTIONS SECTION

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

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

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

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

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:

HOW SUPPLIED SECTION

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

STATEMENT OF IDENTITY SECTION

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

Printed in USA Rev. -06 05/23

©2023 Virbac Corporation. All Rights Reserved. BIOMOX is a registered trademark of the Virbac Group of Companies.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
791939amoxicillin 100 MG Oral TabletPSN11
392151amoxicillin 200 MG Oral TabletPSN11
791947amoxicillin 50 MG Oral TabletPSN11
791942Biomox 100 MG Oral TabletPSN11
791944Biomox 200 MG Oral TabletPSN11
791949Biomox 50 MG Oral TabletPSN11
791942amoxicillin 100 MG Oral Tablet [Biomox]SBD11
791944amoxicillin 200 MG Oral Tablet [Biomox]SBD11
791949amoxicillin 50 MG Oral Tablet [Biomox]SBD11
791939amoxicillin 100 MG Oral TabletSCD11
392151amoxicillin 200 MG Oral TabletSCD11
791947amoxicillin 50 MG Oral TabletSCD11
791942Biomox 100 MG Oral TabletSY11
791944Biomox 200 MG Oral TabletSY11
791949Biomox 50 MG Oral TabletSY11

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
51311-201-50Biomox500 in 1 BOTTLETABLET50011
51311-203-50Biomox500 in 1 BOTTLETABLET50011
51311-205-50Biomox500 in 1 BOTTLETABLET50011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51311-201BIOMOX (AMOXICILLIN) TABLET [VIRBAC AH, INC.]111 package rows20240828_2f628ed5-75cb-47a1-a5e7-2902c6f3d336.zip
51311-203BIOMOX (AMOXICILLIN) TABLET [VIRBAC AH, INC.]111 package rows20240828_2f628ed5-75cb-47a1-a5e7-2902c6f3d336.zip
51311-205BIOMOX (AMOXICILLIN) TABLET [VIRBAC AH, INC.]111 package rows20240828_2f628ed5-75cb-47a1-a5e7-2902c6f3d336.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
amoxicillinACTIVE INGREDIENT804826J2HU1
amoxicillinACTIVE MOIETY804826J2HU1

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
51311-20151311-201-50
51311-20351311-203-50
51311-20551311-205-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
amoxicillin804826J2HUACTIM
amoxicillin804826J2HUACTIM
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.