Label: TYLOVET 100 - tylosin phosphate powder 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/13

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  • Tylovet 100

    FRONT PANEL

    For use in Swine, Beef Cattle and Chicken Feeds Only

    Tylovet 100

    Tylosin Phosphate

    Type A Medicated Article

    Do Not Feed Undiluted

    Equivalent to 100 g Tylosin per Pound

    Swine:

    For increased rate of weight gain and improved feed efficiency.

    For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis.

    For control of swine dysentery associated with Brachyspira hyodysenteriae.

    For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with Tylovet Soluble (tylosin tartrate) drinking water.

    For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

    For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with Tylovet Soluble (tylosin tartrate) in drinking water.

    Beef Cattle:

    For reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.

    Chickens:

    For increased rate of weight gain and improved feed efficiency.

    Laying Chickens

    For improved feed efficiency.

    Broilers and Replacement Chickens:

    To aid in the control of Chronic Respiratory Disease associated with Mycoplasma gallisepticum.

    Important: Must be Thoroughly Mixed in Feeds Before Use.

    Restricted Drug (California)  Use Only as Directed.

    ANADA# 200-484, Approved by FDA

    Manufactured By: Biovet AD                                                         Distributed By: Huvepharma, Inc.

    39, Petar Rakov Str. 4550 Peshtera                                             525 Westpark Drive, Suite 230

    Bulgaria                                                                                         Peachtree, GA 30269

    Huvepharma, and Tylovet are trademarks of Huvepharma.

    To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.

    Net weight: 50 lb (22.68 kg)

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  • BACK PANEL LABEL

    Directions for Use

    Read All Directions Carefully

    Before Mixing and Feeding

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  • SPL UNCLASSIFIED SECTION

    Tylovet 100 Type A Medicated Article

    Net Weight: 50 lbs

    (22.68 kg)

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  • SPL UNCLASSIFIED SECTION

    Do Not Feed Undiluted

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  • ACTIVE INGREDIENT

    Active Drug Ingredient: Tylosin (as tylosin phosphate)....100 g per lb

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  • INACTIVE INGREDIENT

    Ingredients: Roughage products, pregelatinized starch and dipotassium phosphate.

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  • INSTRUCTIONS FOR USE

    Important: Must be Thoroughly Mixed in Feeds Before Use.

    To ensure adequate mixing, an intermediate blending step should be used prior to manufacturing a complete feed. Do not use in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite.

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  • WARNINGS

    Warning: Tylovet 100 may be irritating to unprotected skin and eyes. When mixing and handling Tylovet 100 use protective clothing, impervious gloves and a dust respirator. In case of accidental eye exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seek medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-877-426-7765.

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  • INDICATIONS & USAGE

    Mixing and Feeding

    Directions for Swine Feeds

    For increased rate of weight

    gain and improved feed efficiency

    Feed

    Tylovet 100 per Ton

    of Type C Feed

    Tylosin Per Ton

    of Type C Feed

     Pre-Starter or Starter  0.2   to   1.0 lbs  20   to    100 g
     Grower  0.2   to   0.4 lbs  20   to      40 g
     Finisher  0.1   to   0.2 lbs  10   to      20 g
     Feed continuously as the sole ration

    For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed. Feed continuously as the sole ration.

    For control of swine dysentery. Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (0.4 pound Tylovet 100 per ton) of complete feed until pigs reach market weight.

    For the treatment and control of swine dysentery. Feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylovet 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin tartrate (as Tylovet Soluble) per gallon in drinking water for 3 to 10 days.

    For control of porcine proliferative enteropathies (PPE, ileitis). Feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (1.0 pound Tylovet 100 per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylovet 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin tartrate (as Tylovet Soluble) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylovet. Diagnosis should be confirmed by a veterinarian when results are not satisfactory.

    NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.

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  • SPL UNCLASSIFIED SECTION

    Mixing and Feeding Directions for Beef Cattle Feeds

    Tylovet 100 per Ton of Type C Feed

    Tylosin Per Ton of Type C

    Feed

    For reduction of incidence of liver abscesses in beef cattle associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.

    0.08 to 0.10 lbs

    To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.

    Feed continuously as the sole ration.

    8 to 10 g

    Mixing Directions for Liquid Type B

    Cattle Feeds

    LIMITATIONS:

    1.    pH must be between 4.5 and 6.0.

    2.    For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not 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 described even when not used.

    3.    For liquid feeds stored in mechanical, air, or other agitation - type tank systems: 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 described even when not used.

     4.    Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture.

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  • SPL UNCLASSIFIED SECTION

     Mixing and Feeding Directions for Chicken Feeds  Tylovet 100 Per Ton of Type C Feed Tylosin Per Ton of Type C Feed 
     For increased rate of weight gain and improved feed efficiency.

    0.04 to 0.5 lbs 

    Feed continuously as the sole ration

     4 to 50 g

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  • SPL UNCLASSIFIED SECTION

    Mixing and Feeding Directions for

    Broiler and Replacement Chicken

    Feeds

    Tylovet 100 Per Ton of

    Type C Feed

    Tylosin Per Ton of Type C Feed

     To aid in the control of chronic respiratory

    disease associated with Mycoplasma gallisepticum.

    Broilers

    Replacement Chickens

    8 to 10 lbs

    10 lbs 

     800 to 1000 g

    1000 g

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  • SPL UNCLASSIFIED SECTION

    For Broiler and Replacement Chickens: Administer in the feed to chickens 0 to 5 days of age, follow with second administration in feed for 24 to 48 hours at 3 to 5 weeks of age.

    NOT FOR HUMAN USE

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  • WARNINGS

     WARNING: Withdraw 5 days before slaughter when fed to chickens at 800 to 1000 grams per ton.

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  • SPL UNCLASSIFIED SECTION

    Mixing and Feeding Directions for Laying

    Chicken Feeds

    Tylovet 100 Per Ton of Type C Feed Tylosin Per Ton of Type C Feed
     For improved feed efficiency. Laying Chickens  0.2 to 0.5 lbs   20 to 50 g

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  • STORAGE AND HANDLING

    Store at Room Temperature, 25°C (77°F).

    Avoid moisture.

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

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    TYLOVET 100  
    tylosin phosphate powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:23243-2350
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TYLOSIN PHOSPHATE (TYLOSIN) TYLOSIN 100 g  in 0.45 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23243-2350-1 22.68 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200484 03/01/2012
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma, AD (552691651)
    Establishment
    Name Address ID/FEI Business Operations
    Biovet-AD 645015512 medicated animal feed manufacture, manufacture, analysis, pack, label, api manufacture
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