Biomox

Manufacturer
Virbac AH, Inc. | Medispray Laboratories Private Ltd | Centrient Pharmaceuticals Netherlands | Alcami Missouri Corporation | Alcami Carolinas Corporation
Effective date
2022-01-05
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:41:16

Label at a glance#

ProductBiomox
Active ingredientamoxicillin
Label structure16 sections

Dosage and administration

The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvment is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Veterinary For Oral Suspension
For use in DOGS only.

DESCRIPTION

DESCRIPTION SECTION

BIOMOX® (amoxicillin) is 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

SPL UNCLASSIFIED SECTION

Cherry Flavor, Silicon Dioxide NF, FD&C Red #40, Polyoxyethylene-Polyoxypropylene Glycol, Sodium Benozate, Sodium Citrate, Sodium Saccharin, and Sucrose

ACTION

SPL UNCLASSIFIED SECTION

Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial
wall mucopeptides. Most strains of the following gram-positive and gramnegative bacteria have demonstrated susceptibility to: amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and betahemolytic streptococci, Streptococcus 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) for oral suspension is indicated in the treatment of the following infections in dogs when caused by susceptible strains of organisms:

BACTERIAL DERMATITIS due to Staphylococcus aureus, Streptococcus spp.; Staphylococcus spp.; and E. coli.

SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus, Streptococcus spp.; E. coli, Proteus mirabilis and
Staphylococcus spp.

As is true 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) for oral suspension should not be used in pregnant or breeding
animals.

CAUTION

SPL UNCLASSIFIED 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. Continue for 48 hours after all symptoms have subsided. If no improvment is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

DIRECTIONS FOR MIXING ORAL SUSPENSION

SPL UNCLASSIFIED SECTION

Add sufficient water to the bottle as indicated in the table below and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.

image descriptionimage description

Note: When stored at room temperature or in refrigerator, discard unused portion of reconstituted suspension after 14 days.

SUPPLY

HOW SUPPLIED SECTION

Bimox® (amoxicillin) for oral suspension is supplied in bottles containing 0.75 g of amoxicillin activity in bottles of 15 mL or 1.5 g of amoxicillin
activity in bottles of 30 mL. After reconstitution with the required amount of water, each mL will contain 50 mg of amoxicillin as the trihydrate.

SPL UNCLASSIFIED SECTION

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

92515 07/19 Rev.-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN5
205730amoxicillin 50 MG/ML Oral Suspension [Biomox]SBD5
239191amoxicillin 50 MG/ML Oral SuspensionSCD5
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY5
239191amoxicillin 250 MG per 5 ML Oral SuspensionSY5
205730Biomox 50 MG/ML Oral SuspensionSY5

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
51311-300-15Biomox15 mL in 1 BOTTLE, DROPPERSUSPENSION155
51311-300-30Biomox30 mL in 1 BOTTLE, DROPPERSUSPENSION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51311-300BIOMOX (AMOXICILLIN) SUSPENSION [VIRBAC AH, INC.]52 package rows20220106_b2a9380f-3dd5-4fc6-8f03-2d04e284e1cb.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
51311-30051311-300-15, 51311-300-30

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 · 218 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
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-09-04Warnings, 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
AmoxicillinAMOXICILLINChartwell Governmental & Specialty RX, LLC809393b7-6271-4715-ae84-13fd8f9017722026-07-30Warnings, 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

Reported adverse events (FAERS/openFDA)#

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