21 C.F.R. § 522.784 Doxylamine succinate injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of the drug contains 11.36 mg of doxylamine succinate. (b) Sponsor. See No. 000061 in §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 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter. (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]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.784 Doxylamine succinate injection.
