[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: 21CFR522.784]

[Page 234]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.784  Doxylamine succinate injection.

    (a) Specifications. Each milliliter of the drug contains 11.36 mg of 
doxylamine succinate.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in conditions in which 
antihistaminic therapy may be expected to alleviate some signs of 
disease in horses, dogs, and cats.1
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    1 These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter.
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    (2) It is administered to horses at a dosage level of 25 mg per 
hundred pounds of body weight. It is administered to dogs and cats at a 
dosage level of 0.5 to 1 mg per pound of body weight. Doses may be 
repeated at 8 to 12 hours, if necessary, to produce desired effect. 
Intravenous route is not recommended for dogs and cats and should be 
injected slowly in horses. Intramuscular and subcutaneous administration 
should be by divided injection sites.1
    (3) Not for use in horses intended for food.1
    (4) Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.1

[40 FR 13858, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 
1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, 
Nov. 19, 1997]