This page reprints a manufacturer label. Everything below in quotation marks is copied from amoxi-drop ® (amoxicillin), published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for amoxi-drop ® (amoxicillin) by Zoetis Inc, a amoxicillin product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 3 other stored labels carry the same active ingredient and are listed at the end.
The label
Product: amoxi-drop ® (amoxicillin). Manufacturer: Zoetis Inc. FDA Structured Product Label set id 24fb21f9-7411-4bfd-a3de-1b9356b4ced4. Label effective 2024-11-14. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
Dogs 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 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 .
Dosage and Administration
Dogs 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 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: 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. Do Not Store Dry Powder at Temperatures Above 25°C (77°F)
Contraindications
The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.
Warnings
For use in dogs and cats only. Not for use in animals which are raised for food production.
Adverse Reactions
Amoxicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.
Description
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.
Other labels for this ingredient
These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.
- Approved by FDA under NADA # 065-492 BIOMOX ® (amoxicillin tablets), Virbac AH, Inc.. Set id 2f628ed5-75cb-47a1-a5e7-2902c6f3d336.
- amoxi❖tabs ® (amoxicillin tablets), USP Veterinary Tablets For use in dogs and cats, Zoetis Inc.. Set id 3e7c1569-d19c-4069-bf21-bc5fb9636eb0.
- amoxi❖tabs ® (amoxicillin tablets), USP Veterinary Tablets, Zoetis Inc.. Set id a4ba38ad-77ae-4298-8531-d4ee2f8485ff.
FDA adverse event reports
The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming amoxicillin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.
These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.
Dogs: 6,591 reports
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 1,418 |
| Anorexia | 801 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 720 |
| Elevated alanine aminotransferase (ALT) | 597 |
| Diarrhoea | 569 |
| Death by euthanasia | 538 |
| Lack of efficacy (bacteria) - NOS | 532 |
| Other abnormal test result NOS | 528 |
| Death | 522 |
| Lack of efficacy - NOS | 510 |
| Elevated serum alkaline phosphatase (SAP) | 478 |
| Leucocytosis NOS | 438 |
| Anaemia NOS | 382 |
| Fever | 378 |
| Depression | 369 |
Outcome as recorded by the reporter: Ongoing 1,836; Recovered/Normal 955; Outcome Unknown 920; Died 678; Euthanized 420; Recovered with Sequela 51.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 2,931 reports
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 756 |
| Anorexia | 435 |
| Diarrhoea | 370 |
| Lack of efficacy (bacteria) - NOS | 272 |
| Death | 267 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 240 |
| Death by euthanasia | 226 |
| Depression | 206 |
| Weight loss | 177 |
| Ataxia | 160 |
| Lack of efficacy - NOS | 153 |
| Fever | 147 |
| Dehydration | 125 |
| Not eating | 124 |
| Elevated blood urea nitrogen (BUN) | 115 |
Outcome as recorded by the reporter: Ongoing 524; Outcome Unknown 464; Died 368; Recovered/Normal 331; Euthanized 139; Recovered with Sequela 6.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- amoxi-drop ® (amoxicillin)FDA · retrieved 2026-09-16
“Dogs The recommended dosage is 5 mg/lb of body weight.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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