21 C.F.R. § 520.1196 Ivermectin and pyrantel pamoate chewable tablets.
Title 21 - Food and Drugs
(a) Specifications. Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively. (b) Sponsors. See Nos. 050604, 051311, and 063604 in §510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. A minimum of 6 µg of ivermectin and 5 mg of pyrantel (as pamoate salt) per kilogram (2.72 µg and 2.27 mg per pound) of body weight. (ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for up to a month (30 days) after infection and treatment and control of adult ascarids Toxocara canis and Toxascaris leonina, and adult hookworms Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala. (iii) Limitations. Use monthly. Recommended for dogs 6 weeks of age and older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] [58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1196 Ivermectin and pyrantel pamoate chewable tablets.
