[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.88a]

[Page 98-99]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.88a  Amoxicillin trihydrate film-coated tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate 
equivalent to 50, 100, 150, 200, or 400 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 milligrams per pound 
of body weight, twice a day.
    (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. Administer for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.

[[Page 99]]

    (2) Cats--(i) Amount. 50 milligrams (5 to 10 milligrams per pound of 
body weight) once a day.
    (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. Administer for 5 to 7 days or 48 hours after all 
symptoms have subsided. If no improvement is seen in 5 days, review 
diagnosis and change therapy. 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]