21 CFR § 520.88aChapter I

§ 520.88a Amoxicillin trihydrate film-coated tablets.

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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

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Specifications.(a) Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.

Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.

Conditions of useDogsAmount.(c) —(1) —(i) Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.

Indications for use.Staphylococcus aureus, StreptococcusEscherichia coli, Proteus mirabilis,S. aureus, StreptococcusP. mirabilis.(ii) Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of spp., and bacterial dermatitis caused by spp., and

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

CatsAmount.(2) —(i) Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.

Indications for use.S. aureus, StreptococcusE. coli;S. aureus, StreptococcusE. coli,P. mirabilis;E. coli;S. aureus, StreptococcusE. coli,Pasteurella multocida.(ii) Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to spp., and genitourinary tract (cystitis) due to spp., and gastrointestinal tract due to and skin and soft tissue (abscesses, lacerations, and wounds) due to spp., and

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

[57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, 2014]

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.