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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.1450c

§ 520.1450c. Morantel tartrate sustained-release trilaminate cylinder/sheet.

216 words·~1 min read·/us/cfr/t21/s§ 520.1450c·

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(a)Specifications. The drug product consists of a trilaminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base.
(b)Sponsor. See 054771 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.425 of this chapter.
(d)Conditions of use—(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season.
(2)Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum.
(3)Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014]
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