Label: PAYLEAN 45- ractopamine hydrochloride granule

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

Drug Label Information

Updated June 17, 2019

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  • BOXED WARNING(What is this?)

    WARNING: The active ingredient in Paylean, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Paylean formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Paylean, 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 eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

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  • SPL UNCLASSIFIED SECTION

    Elanco™

    AF0610

    Paylean™ 45

    (ractopamine hydrochloride Type A medicated article)

    For Use in Finishing Swine Feeds Only

    Net Weight 25 lb

    (11.34 Kg)

    Do not feed undiluted.
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  • Active Drug Ingredient:

    ractopamine hydrochloride

    - 45.4 g per Ib (100 g per kg)

    Important: Must be thoroughly mixed into feeds before use. Follow label directions.

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  • Indication:

    For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing not less than 150 Ibs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 Ibs of gain prior to slaughter.

    Appropriate Concentration of Ractopamine in Type C
    Medicated Feed
    4.5 to 9.0 g/ton*
    (5 to 10 ppm)
    * No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton (5 ppm).

    Inert Ingredients: Ground corncobs.

    NC = No Change, ↑ = increased, ↓ = decreased,

    a Improvement was observed only in pigs weighing less than 250 Ibs.

    Variable Last 45 Ibs of body weight gain Last 90 Ibs of body weight gain
    4.5 g/ton ractopamine 9.0 g/ton ractopamine 4.5 g/ton ractopamine 9.0 g/ton ractopamine
    Carcass Fat a a
    10th Rib Backfat (3/4 location) NC NC NC
    Last Rib Backfat (midline) NC NC NC NC
    Loin Eye Area (10th Rib) a
    Rate of Lean Gain
    Efficiency of Lean Gain
    Dressing Percentage NC

    Mixing Directions: Thoroughly mix Paylean 45 Type A Medicated Article into one ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4920 g/ton).

    The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

    Pounds of Paylean 45 To Add Per Ton To Make a Type B Medicated Feed Resulting Ractopamine Concentration in Type B Medicated Feed
    Grams/ton Grams/pound
    19.82 900 0.45
    39.65 1,800 0.90
    59.47 2,700 1.35
    79.30 3,600 1.80

    Thoroughly mix Paylean 45 Type A Medicated Article into one ton of complete swine feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare at least one intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients then add to the remaining feed ingredients to make a ton of complete feed.

    Pounds of Paylean 45 To Add Per Ton of Type C Medicated Feed Resulting Ractopamine
    Concentration in Type C
    Medicated Feed
    0.10 4.5 grams/ton (5 ppm)
    0.20 9 grams/ton (10 ppm)

    Feeding Directions: Feed continuously as the sole ration to finishing swine weighing not less than 150 Ibs for the last 45 to 90 Ibs (group average) of weight gain prior to slaughter.

    CAUTION: Ractopamine may increase the number of injured and/or fatigued pigs during marketing. Not for use in breeding swine.

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  • STORAGE AND HANDLING

    Storage information: Store at less than or equal to 25°C (77°F).

    Excursions to 40°C (104°F) are acceptable.

    Avoid excessive moisture.

    Expiration Date and Lot Number are printed on the bag.

    Not to be used after the expiry date.

    Restricted Drug (California) - Use Only as Directed -

    NADA # 140-863, Approved by FDA

    Paylean™ 45

    TAKE TIME
    OBSERVE LABEL
    DIRECTIONS

    Manufactured for:
    Elanco US Inc
    Greenfield, IN 46140, USA

    To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

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

    BG209771X

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  • Principal Display Panel - Paylean 45 Bag Label

    Elanco™

    AF0610

    Paylean™ 45

    (ractopamine hydrochloride Type A
    medicated article)

    For Use in Finishing Swine Feeds Only

    Net Weight 25 lb

    (11.34 Kg)

    Principal Display Panel - Paylean 45 Bag Label
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  • INGREDIENTS AND APPEARANCE
    PAYLEAN 45 
    ractopamine hydrochloride granule
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-0610
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1) ractopamine hydrochloride 45.5 g  in 0.45 kg
    Inactive Ingredients
    Ingredient Name Strength
    Corn Cob (UNII: XXP8V4H4NY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58198-0610-9 11.34 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA140863 06/06/2008
    Labeler - Elanco US Inc. (966985624)
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