Label: EXPERIOR 50- lubabegron granule

  • Category: OTC ANIMAL DRUG LABEL

Drug Label Information

Updated November 30, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    For Use in Feeds for Beef Steers and Heifers Fed in Confinement for Slaughter

    Important: For further manufacturing only. Experior 50 must be thoroughly mixed into feeds before use. Follow label directions.

    Active Drug Ingredient: Lubabegron (as lubabegron fumarate) - 50 g per kg (22.7 g per lb)

    Inert Ingredients: Corn cob grits, mineral oil, citric acid.

  • Indications for Use:

    For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

    Effectiveness has not been demonstrated when fed for less than 14 days.

    Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.

    Increased rate of weight gain, improved feed efficiency, and increased carcass leanness have not been demonstrated with this product.

    Mixing Directions: Thoroughly mix Experior 50 Type A medicated article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B medicated feed (maximum 720 g/ton). Type B medicated feeds should not be pelleted. The following table gives examples of how some Type B medicated feed concentrations can be prepared:

    a Experior 50 contains 22.7 grams of lubabegron per pound

    b Based on 90% Dry Matter Basis

    Pounds of Experior 50 Type Aa
    To Add Per Ton To Make a Type B Medicated Feed
    Resulting lubabegron Concentration in Type B Medicated Feedb
    grams/ton grams/pound
    2.0 45.4 0.02
    15.4 350 0.17
    31.7 720 0.36

    Thoroughly mix Experior 50 Type A medicated article in a ton of complete cattle feed according to the table below to obtain the proper concentration in the Type C medicated feed. You must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 50 Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend to the remaining feed ingredients to make a complete feed.

    a Experior 50 contains 22.7 grams of lubabegron per pound

    b Based on 90% Dry Matter Basis

    c Value is rounded. Rounded value from 0.0551.

    Pounds of Experior 50 Type Aa
    To Add Per Ton To Make a Type C
    Medicated Feed
    Resulting lubabegron Concentration (g/ton) in Type C Medicated Feedb
    0.06c1.25
    0.11 2.50
    0.20 4.54

    Feeding Directions: Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) of complete feed (90% dry matter basis) to provide 13-90 mg lubabegron/head/day continuously to beef steers and heifers fed in confinement for slaughter as the sole ration during the last 14 to 91 days on feed.

    Caution: Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing Experior 50. A decrease in dry matter intake may be noticed in some animals.

  • Warnings:

    No withdrawal period is required when used according to labeling.

    User Safety Warning: The active ingredient in Experior 50, lubabegron, is a beta-adrenergic agonist/antagonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for human use. Keep out of reach of children. When mixing and handling Experior 50, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water; if wearing contact lenses, rinse eyes first, then remove contact lenses and continue to rinse for 5-20 minutes. If irritation persists, seek medical attention. The safety data sheet contains more detailed occupational safety information. To report adverse drug events, access medical information, or obtain additional product information, call Elanco US Inc. at 1-800-428-4441. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

    Lot No:

    Expiry Date:

  • Storage Information:

    Store at or below 25°C (77°F). Excursions permitted to 30°C (86°F).

    Not to be used after the date printed on the bag.

    Restricted Drug (California) – Use Only as Directed

    Approved by FDA under NADA #141-508

    Manufactured For: Elanco US Inc.
    2500 Innovation Way
    Greenfield, IN 46140, U.S.A.

    Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    Net Weight 10 kg

    (22.04 lb)

    TAKE TIME

    OBSERVE LABEL DIRECTIONS

    YL102500X

  • Principal Display Panel - 50 kg Bag Label

    Elanco

    Experior50

    (lubabegron Type A
    medicated article)

    For Use in Feeds for Beef Steers and Heifers Fed in Confinement for Slaughter

    Principal Display Panel - 50 kg Bag Label
  • INGREDIENTS AND APPEARANCE
    EXPERIOR 50 
    lubabegron granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58198-5567
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lubabegron (UNII: 8501207BZX) (Lubabegron - UNII:8501207BZX) Lubabegron50 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    CORN GRAIN (UNII: C1Z9U7094Z)  
    Mineral oil (UNII: T5L8T28FGP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-5567-150 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14150807/16/2020
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elanco Clinton Laboratories039138631API MANUFACTURE, MANUFACTURE, PACK, LABEL