Label: OPTAFLEXX 45- ractopamine hydrochloride powder

  • 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

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

  • BOXED WARNING(What is this?)

    WARNING: The active ingredient in Optaflexx, 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 Optaflexx 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Optaflexx, 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™

    AF0630

    Optaflexx™45

    (ractopamine hydrochloride Type A medicated article)

    For use in Feeds For Cattle Fed in Confinement for Slaughter Only

    Net Weight 25 lb
    (11.34 kg)

    Do Not Feed Undiluted

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  • SPL UNCLASSIFIED SECTION

    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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  • INDICATIONS & USAGE

    Indication: Complete Feed: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

    Top Dress Feed: For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

    Note: Carcass leanness effects are not an approved indication for use when feeding ractopamine by Top Dress Feeding methods.

    Complete Feed

    a Based on 90% Dry Matter Basis

    Indications Appropriate Concentration of
    Ractopamine in Type C
    Medicated Feed a
    Ractopamine (mg/hd/d)
    Increased Rate of Weight Gain,
    and Improved Feed Efficiency
    8.2 to 24.6 g/ton
    (9 ppm to 27 ppm)
    70-430
    Increased Rate of Weight Gain,
    Improved Feed Efficiency, and
    Increased Carcass Leanness
    9.8 to 24.6 g/ton
    (11 ppm to 27 ppm)
    90-430

    a The effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials.

    NC = No Change, ↑ = Increased, ↓ = Decreased

    b Steers Only

    c Reduction indicates an improvement in USDA Yield Grade.

    Carcass Measurements Effect of Ractopamine a
    8.2 grams/ton
    (9 ppm)
    16.4 grams/ton
    (18 ppm)
    24.6 grams/ton
    (27 ppm)
    Hot Carcass Weight, lbs
    Dressing Percentage, % NC b b
    Carcass Percent Fat, % NC
    12th Rib Fat Thickness, in. NC NC NC
    Average Rib Eye Area, sq. in.
    USDA Yield Grade NC NC c
    Marbling Score NC NC NC
    Rate of Carcass Lean Gain per Day NC
    Efficiency of Carcass Lean Gain per Day NC

    Top Dress Feed

    a Based on 90% Dry Matter Basis

    Indications Appropriate Concentration of Ractopamine in
    Type C Medicated Feed a
    Ractopamine
    (mg/hd/d)
    Increased Rate of
    Weight Gain and
    Improved Feed
    Efficiency
    Appropriate Concentration of Ractopamine in
    a minimum of 1.0 lb Top Dressed Type C
    Medicated Feeda (maximum of 800 g/ton)
    70-400

    Inert Ingredients: Ground corn cobs.

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  • DOSAGE & ADMINISTRATION

    Mixing Directions (Complete Feed): Thoroughly mix Optaflexx 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

    a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound

    b Based on 90% Dry Matter Basis

    Pounds of Optaflexx 45 a
    To Add Per Ton To Make a
    Type B Medicated Feed
    Resulting Ractopamine Concentration in
    Type B Medicated Feed b
    grams/ton grams/pound
    36.1 1,640 0.82
    72.2 3,280 1.64
    108.3 4,920 2.46

    Thoroughly mix Optaflexx 45 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. Prepare an 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 one ton of complete feed.

    a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound

    b Based on 90% Dry Matter Basis

    Pounds of Optaflexx 45 a Per Ton To Make
    a Type C Medicated Feed
    Resulting Ractopamine Concentration in
    Type C Medicated Feed b
    0.18 8.2 grams/ton (9 ppm)
    0.36 16.4 grams/ton (18 ppm)
    0.54 24.6 grams/ton (27 ppm)
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  • DOSAGE & ADMINISTRATION

    Mixing Directions (Liquid Type B Feeds): Thoroughly mix Optaflexx Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 2300 g/ton).

    Maintain supplement pH at 4.5 to 7.5. For stored liquid Type B Medicated Feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use.

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

    a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound

    Pounds of Optaflexx 45 a To Add Per Ton To Make a
    Liquid Type B Medicated Feed
    Resulting Ractopamine Concentration in
    Liquid Type B Medicated Feed
    grams/ton grams/pound
    36.1 1,640 0.82
    44.1 2,000 1.00
    50.7 2,300 1.15
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  • DOSAGE & ADMINISTRATION

    Mixing Directions for Preparing Type C Medicated Top Dress Feed: Thoroughly mix Optaflexx 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type C Medicated Feed (maximum 800 g/ton).

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

    a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound

    b Based on 90% Dry Matter Basis

    Pounds of Optaflexx 45 a To Add Per Ton To
    Make Type C Medicated Top Dress Feed
    Resulting Ractopamine Concentration
    in Type C Top Dress Medicated Feed b
    Top Dress grams/ton grams/pound mg/pound
    2.20 100 0.05 50
    4.41 200 0.10 100
    6.61 300 0.15 150
    8.81 400 0.20 200
    17.62 800 0.40 400
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  • DOSAGE & ADMINISTRATION

    Directions for Use (Complete Feed): Feed continuously to cattle fed in confinement for slaughter as the sole ration for the last 28 to 42 days on feed.

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  • DOSAGE & ADMINISTRATION

    Directions for Use (Type C Medicated Top Dress Feed): Feed continuously to cattle fed in confinement for slaughter a Type C Medicated Feed containing up to a maximum of 800 g/ton ractopamine (see mixing direction table) to provide 70 to 400 mg/head/day for the last 28 to 42 days on feed. Type C Medicated Top Dress Feed must be fed in a minimum of 1.0 lb per head per day to provide 70 to 400 mg/head/day.

    CAUTION: Not for animals intended for breeding.

    NOT FOR HUMAN USE

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  • STORAGE AND HANDLING

    Store at Room Temperature. Avoid 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 # 141-221, Approved by FDA

    TAKE TIME
    OBSERVE LABEL DIRECTIONS

    Optaflexx™ 45

    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.

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

    BG209769X

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  • Principal Display Panel – 25 lb Bag Label

    Elanco™

    AF0630

    Optaflexx™45

    (ractopamine hydrochloride Type A medicated article)

    For use in Feeds For Cattle Fed in Confinement
    for Slaughter Only

    Net Weight 25 lb
    (11.34 kg)

    Principal Display Panel – 25 lb Bag Label
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  • INGREDIENTS AND APPEARANCE
    OPTAFLEXX 45 
    ractopamine hydrochloride powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-0630
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1) ractopamine hydrochloride 45.4 g  in 0.45 kg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58198-0630-9 11.34 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141221 06/03/2010
    Labeler - Elanco US Inc. (966985624)
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