21 CFR § 520.88b - Amoxicillin trihydrate for oral suspension.

---
identifier: "/us/cfr/t21/s520.88b"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.88b - Amoxicillin trihydrate for oral suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.88b"
section_name: "Amoxicillin trihydrate for oral suspension."
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"
---


# 520.88b Amoxicillin trihydrate for oral suspension.

(a) *Specifications.* When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.

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

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

(B) *Indications for use.* Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by *Staphylococcus aureus, Streptococcus* spp., *Escherichia coli,* and *Proteus mirabilis;* genitourinary tract (cystitis) caused by *S. aureus, Streptococcus* spp., *E. coli,* and *P. mirabilis;* gastrointestinal tract (bacterial gastroenteritis) caused by *S. aureus, Streptococcus* spp., *E. coli,* and *P. mirabilis;* bacterial dermatitis caused by *S. aureus, Streptococcus* spp., and *P. mirabilis;* and soft tissues (abscesses, lacerations, and wounds) caused by *S. aureus, Streptococcus* spp., *E. coli,* and *P. mirabilis.*

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

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

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

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

(2) [Reserved]

(c) *Sponsors.* See Nos. 000856 and 051311 in § 510.600(c) of this chapter.

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

(ii) *Indications for use.* Treatment of bacterial dermatitis due to *S. aureus, Streptococcus* spp., *Staphylococcus* spp., and *E. coli,* and soft tissue infections (abscesses, wounds, lacerations) due to *S. aureus, Streptococcus* spp., *E. coli, P. mirabilis* and *Staphylococcus* spp.

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

(2) [Reserved]

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; 81 FR 17607, Mar. 30, 2016]