Amoxi-Drop

Manufacturer
Zoetis Inc.
Effective date
2024-11-14
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:43:51

Label at a glance#

ProductAmoxi-Drop
Active ingredientAMOXICILLIN
Label structure13 sections

Dosage and administration

The recommended dosage is 5 mg/lb of body weight. Administer twice daily for 5–7 days. Continue for 48 hours after all symptoms have subsided. The recommended dosage is 50 mg (5–10 mg/lb). Administer once daily for 5–7 days. Continue for 48 hours after all symptoms have subsided. Add required amount of water (see following table) to the bottle and shake vigorously. Each mL of suspension will contain 50 mg of amoxi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Amoxi-Drop 

(amoxicillin for oral suspension), USP

For veterinary oral suspension

For use in dogs and cats

CAUTION

PRECAUTIONS SECTION

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

DESCRIPTION

DESCRIPTION SECTION

Amoxi-Drop (amoxicillin for oral suspension), USP 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(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

CLINICAL PHARMACOLOGY

SPL UNCLASSIFIED SECTION

Amoxi-Drop 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: α- and β-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

INDICATIONS & USAGE SECTION

Dogs

SPL UNCLASSIFIED SECTION

Amoxi-Drop is 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

SPL UNCLASSIFIED SECTION

Amoxi-Drop is indicated in the treatment of susceptible strains of the organisms causing the following infections:

Upper respiratory tract infections due to Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and Proteus mirabilis.

Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, Proteus mirabilis, and Corynebacterium spp.

Gastrointestinal tract infections due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.

Skin and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS

FOOD SAFETY WARNING SECTION

For use in dogs and cats only. Not for use in animals which are raised for food production.

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

SPL UNCLASSIFIED SECTION

The recommended dosage is 5 mg/lb of body weight. Administer twice daily for 5–7 days. Continue for 48 hours after all symptoms have subsided.

Cats

SPL UNCLASSIFIED SECTION

The recommended dosage is 50 mg (5–10 mg/lb). Administer once daily for 5–7 days. Continue for 48 hours after all symptoms have subsided.

Directions for Mixing Oral Suspension:

SPL UNCLASSIFIED SECTION

Add required amount of water (see following table) to the bottle and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.

Bottle Size Amount of Water Required for Reconstitution
 15 mL 12 mL
 30 mL 23 mL

Note: Any unused portion of the reconstituted suspension must be discarded after 14 days. After mixing, refrigeration preferable, but not required.

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Amoxi-Drop is supplied in 15-mL bottles containing 0.75 g and 30-mL bottles containing 1.5 g of amoxicillin activity. When reconstituted with required amount of water, each mL contains 50 mg of amoxicillin as the trihydrate.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 055-085

PRODUCT OF SPAIN

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Revised: February 2019
P1518394

PRINCIPAL DISPLAY PANEL - 15 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL Label
15 mL Label

PRINCIPAL DISPLAY PANEL - 30 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL Label
30 mL Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
239191amoxicillin 250 MG in 5 mL Oral SuspensionPSN5
897052amoxicillin 50 MG/ML Oral Suspension [Amoxi Drop]SBD5
239191amoxicillin 50 MG/ML Oral SuspensionSCD5
897052Amoxi-Drop 50 MG/ML Oral SuspensionSY5
239191amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral SuspensionSY5
239191amoxicillin 250 MG per 5 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
54771-6036-1Amoxi-Drop30 mL in 1 BOTTLE, DROPPERSUSPENSION305
54771-6036-6Amoxi-Drop15 mL in 1 BOTTLE, DROPPERSUSPENSION155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-6036AMOXI-DROP (AMOXICILLIN) SUSPENSION [ZOETIS INC.]52 package rows20241116_24fb21f9-7411-4bfd-a3de-1b9356b4ced4.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
54771-603654771-6036-6, 54771-6036-1

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.