21 C.F.R. § 520.1242b Levamisole hydrochloride tablet or oblet (bolus).
Title 21 - Food and Drugs
(a) Chemical name. (-)-2,3,5,6-Tetrahydro-6-phenylimidazo [2,1-b] thiazole monohydrochloride. (b) Specifications. Assay of not less than 98 percent by nonaqueous titration with 0.1 N potassium isopropoxide; 1 isomer minimum 95 percent pure by optical rotation. (c) Sponsor. See Nos. 000061 and 053501 in §510.600(c) of this chapter. (d) Required labeling. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (e) Related tolerances. See §556.350 of this chapter. (f) Conditions of use. (1) It is used in an oblet for cattle as follows: (i) Amount. 2.19 grams per oblet. (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus). (iii) Limitations. Administer as a single dose as follows: 250 to 450 pounds, (2) It is used in a tablet for sheep as follows: (i) Amount. 0.184 gram per tablet. (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus). (iii) Limitations. Administer one tablet for each 50 pounds of body weight; conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not slaughter for food within 72 hours of treatment; consult a veterinarian before using in severely debilitated animals. [40 FR 13838, Mar. 27, 1975, as amended at 44 FR 59507, Oct. 16, 1979; 62 FR 61625, Nov. 19, 1997; 67 FR 63055, Oct. 10, 2002]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1242b Levamisole hydrochloride tablet or oblet (bolus).
