[Title 21 CFR 520.1242b]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS]
[Sec. 520.1242b - Levamisole hydrochloride tablet or oblet (bolus).]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  520.1242b
  Sec. 520.1242b
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    ORAL DOSAGE FORM NEW ANIMAL DRUGS
  


Sec. 520.1242b   Levamisole hydrochloride tablet or oblet (bolus).

    (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. 011716 and 043781 in Sec. 510.600(c) of this 
chapter.

[[Page 177]]

    (d) Required labeling. Consult your veterinarian for assistance in 
the diagnosis, treatment, and control of parasitism.
    (e) Related tolerances. See Sec. 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, \1/2\ oblet; 450 to 750 pounds, 1 oblet; and 750 to 1,050 
pounds, 1\1/2\ oblets; 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) 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]