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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.1872

§ 520.1872. Praziquantel, pyrantel pamoate, and febantel tablets.

268 words·~1 min read·/us/cfr/t21/s§ 520.1872·

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(a)Specifications. Each tablet or chewable tablet contains either:
(1)Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or
(2)Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel.
(3)Tablet No. 3: 136 milligrams
(mg)praziquantel, 136 mg pyrantel base, and 680.4 mg febantel.
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Dogs—(i) Amount. Administer as a single dose directly by mouth or in a small amount of food as follows: Weight of animal Number of tablets per dose Kilograms Pounds Tablet no. 1 Tablet no. 2 Tablet no. 3 0.9 to 1.82 to 41/2 2.3 to 3.25 to 71 3.6 to 5.48 to 121 1/2 5.9 to 8.213 to 182 8.6 to 11.419 to 252 1/2 11.8 to 13.626 to 30 1 14.1 to 20.031 to 44 1 1/2 20.4 to 27.245 to 60 21 27.7 to 40.961 to 90 1 1/2 41.3 to 54.591 to 120 2
(ii)Indications for use. For the removal of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus); hookworms (Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, Toxascaris leonina); and whipworms (Trichuris vulpis) and for the removal and control of tapeworm Echinococcus multilocularis in dogs.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)[Reserved] [59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022]
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§ 520.1872
Praziquantel, pyrantel pamoate, and febantel tablets.
Fed. Reg.×3
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