21CFR520.1199

(a) Specifications. Each chewable tablet or soft chewable tablet contains: (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter . (c) Conditions of use in dogs — (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel. (1) Amount. Administer monthly according to body weight as follows: (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section. (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section. (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section. (iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section. (v) Greater than 100 lb: use the appropriate combination of tablets. (2) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm ( Toxocara canis, Toxascaris leonina ), hookworm ( Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense ) and tapeworm ( Dipylidium caninum, Taenia pisiformis ) infections. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.