[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.90b]

[Page 97]
 
                        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. 520.90b  Ampicillin trihydrate tablets.

    (a) Specifications. Each tablet contains ampicillin trihydrate 
equivalent to 50 or 100 milligrams of ampicillin.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. Dogs--(1) Amount. 5 milligrams per pound of 
body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be 
continued 36 to 48 hours after all symptoms have subsided. If no 
improvement is seen within 5 days, stop treatment, reevaluate diagnosis, 
and change therapy.
    (2) Indications for use. Oral treatment of infections caused by 
susceptible organisms as follows: Upper respiratory infections, 
tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus 
spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary 
tract infections (cystitis) due to Streptococcus spp., Staphylococcus 
spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal 
infections due to Staphylococcus spp., Streptococcus spp., Enterococcus 
spp., and E. coli.; infections associated with abscesses, lacerations, 
and wounds caused by Staphylococcus spp., and Streptococcus spp.
    (3) Limitations. Not for use in animals which have shown 
hypersensitivity to penicillin or for infections caused by 
penicillinase-producing organisms. Not for use in animals which are 
raised for food production. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]