21 CFR § 520.88f - Amoxicillin trihydrate tablets.

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


# 520.88f Amoxicillin trihydrate tablets.

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

(b) *Sponsors.* See Nos. 051311 and 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer 5 mg per pound of body weight twice daily for 5 to 7 days or 48 hours after all symptoms have subsided.

(2) *Indications for use.* For treatment of bacterial dermatitis due to *Staphylococcus aureus, Streptococcus* spp., *Staphylococcus* spp., and *Escherichia coli;* and soft tissue infections (abscesses, wounds, lacerations) due to *S. aureus, Enterococcus faecalis, E. coli, Proteus mirabilis,* and *Staphylococcus* spp.

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

[79 FR 28817, May 20, 2014, as amended at 83 FR 64740, Dec. 18, 2018]