21 C.F.R. § 520.784 Doxylamine succinate tablets.
Title 21 - Food and Drugs
(a) Specifications. The drug is in tablet form and contains doxylamine succinate as the active drug ingredient. (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 orally to horses at a dosage level of 1 to 2 milligrams per pound of body weight per day divided into 3 or 4 equal doses. It is administered orally to dogs and cats at a dosage level of 2 to 3 milligrams per pound of body weight per day divided into 3 or 4 equal doses.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 13838, 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 61624, Nov. 19, 1997]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.784 Doxylamine succinate tablets.
