(a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.
(b) Sponsors. See sponsors in Sec. 510.600(c) for use as follows:
(1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g package as in paragraph (e)(3) of this section.
(2) No. 054771 for use of a 46.8-g package as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph (e)(3) of this section.
(3) No. 057561 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section.
(4) No. 059130 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in paragraph (e)(3) of this section.
(c) Related tolerances. See Sec. 556.350 of this chapter.
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) Conditions of use. It is used as an anthelmintic as follows:
(1) Cattle--(i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench.
(i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench.
(ii) Indications for use--(A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum); and lungworms (Dictyocaulus).
(A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum); and lungworms (Dictyocaulus).
(B) Effective against the following adult nematode infections: Stomach worms (Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei); intestinal worms (T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum); and lungworms (Dictyocaulus viviparus).
(iii) Limitations. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult your veterinarian before using in severely debilitated animals.
(2) Sheep--(i) Amount. 8 mg/kg body weight as a drench.
(i) Amount. 8 mg/kg body weight as a drench.
(ii) Indications for use--(A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia); and lungworms (Dictyocaulus).
(A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia); and lungworms (Dictyocaulus).
(B) Effective against the following adult nematode infections: Stomach worms (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta); intestinal worms (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina), and lungworms (Dictyocaulus filaria).
(iii) Limitations. Do not slaughter for food within 72 hours of treatment. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult veterinarian before using in severely debilitated animals.
(3) Swine--(i) Amount. 8 mg/kg body weight in drinking water.
(i) Amount. 8 mg/kg body weight in drinking water.
(ii) Indications for use. Effective against the following nematode infections: Large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), intestinal thread worms (Strongyloides ransomi) and lungworms (Metastrongylus spp. ).
(iii) Limitations. Do not administer within 72 hours of slaughter for food. Pigs maintained under conditions of constant exposure to worms may require retreatment within 4 to 5 weeks after the first treatment. Consult your veterinarian before administering to sick swine. [69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014] Sec. 520.1242b Levamisol boluses or oblets.
(a) Specifications. Each bolus contains 2.19 grams levamisol hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride.
(b) Sponsors. See Nos. 000061 and 054771 in Sec. 510.600(c) of this chapter.
(c) Required labeling. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
(d) Related tolerances. See Sec. 556.350 of this chapter.
(e) Conditions of use--(1) Cattle--(i) Amount. Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, \1/2\ bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1\1/2\ boluses.
(1) Cattle--(i) Amount. Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, \1/2\ bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1\1/2\ boluses.
(i) Amount. Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, \1/2\ bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1\1/2\ boluses.
(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. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Consult veterinarian before using in severely debilitated animals.
(2) Sheep--(i) Amount. Administer orally one 0.184-gram oblet for each 50 pounds of body weight.
(i) Amount. Administer orally one 0.184-gram oblet for each 50 pounds of body weight.
(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. 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. [78 FR 28822, May 20, 2014] Sec. 520.1242c Levamisol and piperazine.
(a) Specifications. (1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.
(1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base.
(2) A soluble powder which when constituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals.
(1) Amount. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals.
(2) Indications for use. An anthelmintic effective against infections of large strongyles (Strongylus vulgaris, S. edentatus), small strongyles (Cylicocercus spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), ascarids (Parascaris equorum), and pinworms (Oxyuris equi).
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [78 FR 28823, May 20, 2014] Sec. 520.1242d Levamisole resinate.
(a) Specifications. The drug is levamisole adsorbed on a resin, in a concentration equivalent to 10 percent levamisole hydrochloride. Each 2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 grams of levamisole hydrochloride.
(b) Sponsor. See No. 043781 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.350 of this chapter.
(d) Conditions of use. In swine it is used as follows:
(1) Amount. The equivalent of 8 milligrams per kilogram of body weight, as a single dose, mixed in the animal's ration.
(2) Indications for use. For the removal of and control of the following nematode infections: large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), and swine kidney worms (Stephanurus dentatum).
(3) Limitations. For pigs from weaning to market weight, mix one 58.1-gram packet of levamisole resinate containing the equivalent of 10-percent levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medicated feed per 40 pounds of body weight as sole ration. For breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and administer 1 pound of medicated feed per 100 pounds of body weight as sole ration. Administer as single doses. Withhold regular feed overnight and administer medicated feed the following morning. Do not withhold water during fasting. Do not treat within 72 hours of slaughter. Salivation or muzzle foam may be observed. The reaction will disappear a short time after feeding. If pigs are infected with mature lungworms, coughing and vomiting may be observed. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980] Sec. 520.1242e Levamisole hydrochloride effervescent tablets.
(a) Specifications. Each tablet contains 907 milligrams of levamisole hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.350 of this chapter.
(d) Conditions of use. It is used for swine as follows:
(1) Amount. The equivalent of 8 milligrams of levamisole hydrochloride per kilogram of body weight, as a single dose.
(2) Indications for use. See Sec. 520.1242a(f)(3)(ii).
(3) Limitations. Withholding water from pigs before treatment is not necessary. Add one tablet for each 2\1/2\ gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular water. Pigs maintained under conditions of constant worm exposure may require re-treatment within 4 to 5 weeks. Consult your veterinarian before administering to sick swine. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not administer within 72 hours of slaughter for food. [45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] Sec. 520.1242f Levamisol gel.
(a) Specifications. Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride.
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.350 of this chapter.
(d) Conditions of use--(1) Cattle--(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose.
(1) Cattle--(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose.
(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose.
(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. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not administer to cattle within 6 days of slaughter for food; do not administer to dairy animals of breeding age; consult veterinarian before using in severely debilitated animals.
(2) Breeding swine--(i) Amount. Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose.
(i) Amount. Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose.
(ii) Conditions of use. For treating breeding swine infected with the following nematodes: Large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), and kidney worms (Stephanurus dentatus).
(iii) Limitations. May require retreatment in 4 to 5 weeks. Do not use within 11 days of slaughter for food. Consult your veterinarian for assistance before using in severely debilitated animals and in the diagnosis, treatment, and control of parasitism. [47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 FR 11429, Mar. 18, 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] Sec. 520.1242g Levamisole resinate and famphur paste.
(a) Specifications. The drug is a paste containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 percent famphur.
(b) Sponsor. See 000061 in Sec. 510.600(c) of this chapter.
(c) Special considerations. Do not use any cholinesterase-inhibiting drugs, pesticides, insecticides, or chemicals on cattle simultaneously or within a few days before or after treatment with this product.
(d) Related tolerances. See Sec. Sec. 556.273 and 556.350 of this chapter.
(e) Conditions of use in cattle--(1) Amount. 8 milligrams of levamisole hydrochloride (equivalent) and 30 milligrams of famphur activity per kilogram of body weight.
(1) Amount. 8 milligrams of levamisole hydrochloride (equivalent) and 30 milligrams of famphur activity per kilogram of body weight.
(2) Indications for use. For treatment of cattle infected with the following parasites: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), lungworms (Dictyocaulus), cattle grubs (Hypoderma), biting lice (Bovicola), and sucking lice (Linognathus, Solenoptes).
(3) Limitations. Drug is not effective against lice eggs. Conditions of constant helminth and ectoparasitic exposure may require retreatment within 2 to 4 weeks after first treatment. Do not administer to cattle within 19 days of slaughter. Do not administer to dairy animals of breeding age. Do not use in calves less than 3 months old, or in debilitated animals. Do not treat Brahman bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. [53 FR 23757, June 24, 1988, as amended at 54 FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997; 78 FR 28823, May 20, 2014]