[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: 21CFR520.88b]

[Page 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. 520.88b  Amoxicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (1) Conditions of use--(i) Dogs--(A) Amount. 5 milligrams per pound 
of body weight twice daily.
    (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. Use for 5 to 7 days or 48 hours after all symptoms 
have subsided. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (ii) Cats--(A) Amount. 50 milligrams (5 to 10 milligrams per pound) 
once daily.
    (B) Indications for use. Treatment of infections caused by 
susceptible strains of organisms as follows: upper respiratory tract due 
to Staphylococcus spp., Streptococcus spp., Hemophilus 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. Use for 5 to 7 days or 48 hours after all symptoms 
have subsided. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) [Reserved]
    (c) Sponsor. See Nos. 000031 and 000093 in Sec. 510.600(c) of this 
chapter.
    (1) Conditions of use. Dogs--(i) Amount. 5 milligrams per pound of 
body weight twice daily.
    (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. Use for 5 to 7 days. Continue for 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.
    (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]