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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1242b]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

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 § 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 § 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.

(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.

(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]

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