|
(a) Specifications. Each chewable tablet or soft chewable tablet contains:
(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.
(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs - (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.
[71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014; 83 FR 14587, Apr. 5, 2018]
| 
