21 CFR § 520.88a - Amoxicillin trihydrate film-coated tablets.

---
identifier: "/us/cfr/t21/s520.88a"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.88a - Amoxicillin trihydrate film-coated tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.88a"
section_name: "Amoxicillin trihydrate film-coated tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.88a Amoxicillin trihydrate film-coated tablets.

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

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

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

(ii) *Indications for use.* 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 *Staphylococcus aureus, Streptococcus* spp., *Escherichia coli, Proteus mirabilis,* and bacterial dermatitis caused by *S. aureus, Streptococcus* spp., and *P. mirabilis.*

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

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

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

(iii) *Limitations.* 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]