Label: MGA 200- melengestrol acetate granule

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated May 12, 2021

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  • SPL UNCLASSIFIED SECTION

    MGA® 200

    (melengestrol acetate Type A medicated article)

    Heifers Fed in Connement for Slaughter:

    For Increased Rate of Weight Gain, Improved Feed Efficiency and Suppression of Estrus (Heat).

    Heifers Intended for Breeding:

    For Suppression of Estrus (Heat).

  • SPL UNCLASSIFIED SECTION

    Each pound contains:

     

    Active Drug Ingredient:

    Melengestrol Acetate ……………… 200 mg

    Inactive Ingredients:

     Soybean hulls, #20 grind …………… 96.0%

    Starch ………………………………… 2.98%

    Mineral Oil ………………………………1.0%

     

    Store in a Dry Place to Prevent Caking.

     

    Store below 25°C (77°F), excursions permitted to 40°C (104°F).

    Use only as directed. Excessive contact with skin should be avoided. Destroy empty container. Do not reuse.

    Caution:
    For manufacturing, processing or repacking. To be mixed with feed prior to animal use.

    Approved by FDA under NADA # 039-402

    Net Weight 50 Lb (22.7 kg)

  • DIRECTIONS FOR USE:

    Heifers Fed in Confinement for Slaughter: MGA 200 (melengestrol acetate Type A medicated article) should be thoroughly mixed in the supplement to provide 0.25 to 0.50 mg of melengestrol acetate per head per day. Average daily intakes approximating the middle of this range provide the most optimal and economical improvements in rate of gain and feed utilization. Constant daily intakes of 0.35 to 0.50 mg per head per day give a high degree of estrus suppression. Levels of 0.25 to 0.35 mg provide a lower but still effective degree of estrus suppression.

    Heifers Intended for Breeding: MGA 200 should be thoroughly mixed in the supplement to provide 0.5 mg of melengestrol acetate per head per day.

    NOT FOR HUMAN USE.

    CAUTION: Not effective in steers and spayed heifers.

    Heifers Fed in Confinement for Slaughter: Withdrawal periods of three to five days or more should be avoided to prevent the possibility that the heifers may come into estrus (heat) at loading time.

    Heifers Intended for Breeding:

    Do not exceed 24 days of feeding of melengestrol acetate to heifers intended for breeding. A reduced conception rate can be expected if heifers are bred at estruses observed within 1 to 12 days after withdrawal of melengestrol acetate, whereas heifers bred at subsequent observed estruses are expected to have normal conception rates.

  • Mixing Directions

    Thoroughly mix 1.25 to 10 pounds of MGA 200 per ton of non-medicated feed to prepare a Type C medicated feed containing 0.25 to 2.0 grams of melengestrol acetate per ton. The following Table may be used as a guide in determining the amount of MGA 200 to be added to prepare a ton of Type C medicated feed.

     

    Amount of
    Type C Feed Fed
    (lb/head/day)
     

    Melengestrol
    Acetate
    (mg/head/day)

    Pounds MGA 200 per Ton 
    of Type C Feed

     0.5  0.25  5.00
     0.5  0.30  6.00
     0.5  0.35  7.00 
     0.5  0.40  8.00
     0.5  0.45  9.00
     0.5  0.50 10.00 
     1.0  0.25  2.50
     1.0  0.30  3.00
     1.0  0.35  3.50
     1.0  0.40  4.00
     1.0  0.45  4.50
     1.0  0.50  5.00
     1.5  0.25  1.67
     1.5  0.30  2.00
     1.5  0.35  2.33
     1.5  0.40  2.67
     1.5  0.45  3.00
     1.5  0.50  3.33
     2.0  0.25  1.25
     2.0  0.30  1.50
     2.0  0.35  1.75
     2.0  0.40  2.00
     2.0  0.45  2.25
     2.0  0.50  2.50

    Type B medicated feeds containing 4 to 10 grams melengestrol acetate per ton may be manufactured by thoroughly mixing 20 to 50 lbs of MGA 200 with 1980 to 1950 lbs of non-medicated feed. Labeling for such Type B feeds shall contain directions for manufacturing Type C medicated feeds containing 0.25 to 2.0 grams melengestrol acetate per ton (0.125–1.0 mg/lb). The Type C medicated feed, containing melengestrol acetate, must be top dressed on grain or roughage or mixed with a complete ration at the rate of 0.5 to 2.0 pounds per head per day.

    Good manufacturing practice regulations must be adhered to in manufacturing feeds containing MGA 200.

  • SPL UNCLASSIFIED SECTION

    Restricted Drug (California)—Use Only as Directed

    zoetis


    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    50743801

  • Principal Display Panel - Bag Label

    Bag Label

  • INGREDIENTS AND APPEARANCE
    MGA  200
    melengestrol acetate granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-1952
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELENGESTROL ACETATE (UNII: 4W5HDS3936) (MELENGESTROL - UNII:BX98J4T6JU) MELENGESTROL ACETATE200 mg  in 0.45 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1952-118 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03940211/30/2011
    Labeler - Zoetis Inc. (828851555)