Label: CYCLEGUARD 500- melengestrol acetate liquid

  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated May 12, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CycleGuard® 500

    (melengestrol acetate Type A liquid medicated article)

    Heifers Fed in Confinement 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).

    Each Pound Contains:
       Active Drug Ingredient:
          Melengestrol Acetate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 mg
          (as melengestrol acetate and its propylene glycol ketal)
     Inactive Ingredient:
          Propylene Glycol, U.S.P. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99.89%

  • PRECAUTIONS

    PRECAUTIONS: For manufacturing, processing, or repacking. To be mixed with feed prior to animal use.
    Use only as directed. Excessive contact with skin should be avoided. Destroy empty container. Do not reuse.

  • STORAGE AND HANDLING

    Store at 4° - 25°C (39° - 77°F).
    Excursions permitted up to 40°C (104°F).
    Approved by FDA under ANADA #200-399
    Net Weight 40 Pounds (18 kg)
    (4.627gal [17.5 L])

    HUVEPHARMA®

    KCP-S00037
    Version 02 Rev. 02-2022

  • INDICATIONS & USAGE

    DIRECTIONS FOR USE:
    Heifers Fed in Confinement for Slaughter:
    CycleGuard 500 (melengestrol acetate Type A liquid medicated article) should be thoroughly
    mixed in liquid Type C medicated feed which must be fed at 0.5 to 2.0 pounds per head daily
    to provide 0.25 to 0.5 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:
    CycleGuard 500 should be thoroughly mixed in the supplement to provide 0.5 mg of melengestrol
    acetate per head per day.

  • WARNINGS AND PRECAUTIONS

    WARNINGS: Not for human use. Restricted Drug (California)—Use Only As Directed
    PRECAUTIONS: Not effective in steers and spayed heifers.

  • INDICATIONS & USAGE

    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.

  • DOSAGE & ADMINISTRATION

    MIXING DIRECTIONS:
    Liquid Type B and C medicated feeds containing melengestrol acetate must have
    a pH of 4.0 to 8.0 and their labels must bear appropriate mixing directions.
    Mixing directions for liquid Type B or C feeds stored in recirculation tank
    systems are: "Recirculate immediately prior to use for no less than 10 minutes,
    moving not less than 1 percent of the tank contents per minute from the bottom
    of the tank to the top. Recirculate daily, as directed in this paragraph even
    when the Type B (or C) feed is not used." Mixing directions for liquid Type B
    and C feeds stored in mechanical, air or other agitation-type tank systems are:
    "Agitate immediately prior to use for not less than 10 minutes, creating a
    turbulence at the bottom of the tank that is visible at the top. Agitate daily,
    as directed in this paragraph, even when the Type B (or C) feed is not used."
    Intermediate medicated feeds should not be made from CycleGuard 500 except as
    a part of a continuous mixing operation to make a complete liquid Type B or
    Type C medicated feed.
    Thoroughly mix 0.5 to 4 pounds of CycleGuard 500 per ton of a 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 CycleGuard 500 to be added to prepare a ton
    of Type C medicated feed.

  • DOSAGE & ADMINISTRATION

    Dosing Table

    Type B medicated feed containing 4 to 10 grams melengestrol acetate per ton may
    be manufactured by thoroughly mixing 8 to 20 lbs of CycleGuard® 500 (melengestrol
    acetate Type A liquid medicated article) with 1992 to 1980 lbs of non-medicated
    feed. Labeling for such Type B feed shall contain directions for manufacturing
    Type C medicated feeds containing 0.25 to 2.0 grams melengestrol acetate per ton
    (0.125 to 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 CycleGuard 500.

  • ADVERSE REACTIONS

    To report suspected adverse drug events, for technical assistance or to obtain a copy
    of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
    www.huvepharma.us. For additional information about adverse drug experience reporting
    for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under ANADA #200-399

    Manufactured For: Huvepharma, Inc
    525 Westpark Dr. Suite 230
    Peachtree City, GA 30269
    1-877-994-4883

    HUVEPHARMA®

  • PRINCIPAL DISPLAY PANEL

    CycleGuard 500 label page 1

  • PRINCIPAL DISPLAY PANEL

    CycleGuard 500 label page 2

  • PRINCIPAL DISPLAY PANEL

    CycleGuard 500 label page 3

  • INGREDIENTS AND APPEARANCE
    CYCLEGUARD  500
    melengestrol acetate liquid
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:23243-0068
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELENGESTROL ACETATE (UNII: 4W5HDS3936) (MELENGESTROL - UNII:BX98J4T6JU) MELENGESTROL ACETATE500 mg  in .45 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-0068-118 kg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20039902/21/2021
    Labeler - Huvepharma, Inc (619153559)