amoxi❖tabs ® (amoxicillin tablets), USP Veterinary Tablets

Manufacturer
Zoetis Inc.
Effective date
2024-11-14
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:43:53

Label at a glance#

ProductAmoxi-Tabs
Active ingredientAMOXICILLIN
Label structure14 sections

Indications and uses

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 trac...

Dosage and administration

Dogs: The recommended dosage is 5 mg/lb of body weight twice a day. Cats: The recommended dosage is 50 mg (5–10 mg/lb) once a day. Dosage should be continued for 5–7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy.

Storage and handling

Do Not Store at Temperatures Above 25°C (77°F) Keep Bottle Tightly Closed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For use in dogs and cats

CAUTION

SPL UNCLASSIFIED SECTION

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

DESCRIPTION

DESCRIPTION SECTION

Amoxi-Tabs (amoxicillin tablets) is a semisynthetic antibiotic with a broad spectrum of activity. It provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Chemically, it is D(-)-a-amino-p-hydroxybenzyl penicillin trihydrate.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

INDICATIONS AND USAGE

VETERINARY INDICATIONS SECTION

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

CONTRAINDICATIONS SECTION

 The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

WARNING

WARNINGS SECTION

For use in dogs and cats only

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

 Amoxicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dogs: The recommended dosage is 5 mg/lb of body weight twice a day.

Cats: The recommended dosage is 50 mg (5–10 mg/lb) once a day.

Dosage should be continued for 5–7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy.

STORAGE AND HANDLING SECTION

Do Not Store at Temperatures Above 25°C (77°F)

Keep Bottle Tightly Closed.

HOW SUPPLIED

HOW SUPPLIED SECTION

 Amoxi-Tabs are supplied in 5 strengths: 50 mg, 100 mg, 150 mg, and 200 mg in bottles of 500 tablets; 400 mg in bottles of 250 tablets.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 055-078
Approved by FDA under NADA # 055-081

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

P1523357
Revised: January 2020

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mg Tablet Bottle Label
50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mg Tablet Bottle Label
100 mg Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1360635Amoxi-tabs 100 MG Oral TabletPSN6
1360637Amoxi-tabs 50 MG Oral TabletPSN6
791939amoxicillin 100 MG Oral TabletPSN6
791947amoxicillin 50 MG Oral TabletPSN6
1360635amoxicillin 100 MG Oral Tablet [Amoxi-tabs]SBD6
1360637amoxicillin 50 MG Oral Tablet [Amoxi-tabs]SBD6
791939amoxicillin 100 MG Oral TabletSCD6
791947amoxicillin 50 MG Oral TabletSCD6
1360635Amoxi-tabs 100 MG Oral TabletSY6
1360637Amoxi-tabs 50 MG Oral TabletSY6

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
54771-6042-2Amoxi-Tabs500 in 1 BOTTLETABLET, FILM COATED5006
54771-6043-3Amoxi-Tabs500 in 1 BOTTLETABLET, FILM COATED5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-6042AMOXI-TABS (AMOXICILLIN) TABLET, FILM COATED [ZOETIS INC.]61 package rows20241116_a4ba38ad-77ae-4298-8531-d4ee2f8485ff.zip
54771-6043AMOXI-TABS (AMOXICILLIN) TABLET, FILM COATED [ZOETIS INC.]61 package rows20241116_a4ba38ad-77ae-4298-8531-d4ee2f8485ff.zip

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
54771-604254771-6042-2
54771-604354771-6043-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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.