21 C.F.R. § 520.2100 Selenium, vitamin E capsules.
Title 21 - Food and Drugs
(a) Specifications. The capsules contain 2.19 milligrams of sodium selenite (equivalent to 1 milligram of selenium) and 56.2 milligrams of vitamin E (68 I.U.) (as d-alpha tocopheryl acid succinate) or 0.548 milligram of sodium selenite (equivalent to .25 milligram of selenium and 14 milligrams of vitamin E (17 I.U.) (as d-alpha tocopheryl acid succinate.) (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is intended for use as an aid in alleviating and controlling inflammation, pain, and lameness associated with certain arthropathies in dogs. (2) The capsules are administered orally with the larger capsules administered at a dosage level of 1 capsule per 20 pounds of body weight to a maximum of 5 capsules with the dosage repeated at 3 day intervals until a satisfactory therapeutic response is observed. A maintenance dosage is then administered consisting of 1 capsule per 40 pounds of body weight, with a minimum of 1 capsule per 40 pounds of body weight, with a minimum of 1 capsule, given every 3 days, or 7 days, or longer, as required to maintain improvement or an asymptomatic condition. For dogs under 20 pounds of body weight, the small capsules are administered orally at a dosage level of 1 per 5 pounds of body weight with a minimum of 1 capsule which dosage is repeated at 3 day intervals until a satisfactory response is observed then a maintenance regimen is initiated with 1 capsule per 10 pounds of body weight, minimum of 1 capsule, every 3 days, or 7 days, or longer as required to maintain continued improvement or an asymptomatic condition. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 52 FR 9756, Mar. 26, 1987]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2100 Selenium, vitamin E capsules.
