Label: TYLAN 50- tylosin injection, solution 

  • Label RSS
  • NDC Code(s): 0986-0205-11
  • Packager: Elanco Animal Health Co
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 07/13

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

  • SPL UNCLASSIFIED SECTION

    Elanco™ AH0205 YL086437AMA

    For Use In Cattle and Swine Only
    An Antibiotic

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  • Indications:

    In Beef Cattle and Non-lactating Dairy Cattle, Tylan 50 Injection is indicated for use in the treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes.

    In Swine, Tylan 50 Injection is indicated for use in the treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.

    Each mL contains 50 mg of tylosin activity (as tylosin base) in 50 percent propylene glycol with 4 percent benzyl alcohol and water for injection.

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  • ADMINISTRATION AND DOSAGE:

    Tylan 50 Injection is administered intramuscularly.

    BEEF CATTLE AND NON-LACTATING DAIRY CATTLE—

    Inject intramuscularly 8 mg per pound of body weight one time daily (1 mL per 6.25 pounds). Treatment should be continued 24 hours following remission of disease signs, not to exceed 5 days. Do not inject more than 10 mL per site.

    This formulation is recommended for use in calves weighing less than 200 pounds.

    SWINE—Inject intramuscularly 4 mg per pound of body weight (1 mL per 12.5 pounds) twice daily. Treatment should be continued 24 hours following remission of disease signs, not to exceed 3 days. Do not inject more than 5 mL per site.

    Read accompanying directions fully before use.

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  • CAUTION:

    Do not mix Tylan 50 Injection with other injectable solutions as this may cause a precipitation of the active ingredients.

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  • WARNINGS:

    NOT FOR HUMAN USE, KEEP OUT OF REACH OF CHILDREN.

    Adverse reactions, including shock and death may result from overdosage in baby pigs.

    Do not attempt injection into pigs weighing less than 6.25 pounds (0.5 mL) unless the syringe is capable of accurately delivering 0.1 mL. Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.

    RESIDUE WARNING: Swine:

    Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product.

    RESIDUE WARNING: Cattle:

    Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/ or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. If tylosin medicated drinking water is used as a follow-up treatment for swine dysentery the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.

    Store at or below 25°C (77°F)

    Elanco, Tylan and the diagonal bar are trademarks owned or licensed by

    Eli Lilly and Company, its subsidiaries or affiliates

    Restricted Drug (California) - Use Only as Directed.

    NADA 12-965, Approved by FDA

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

    Manufactured for: Elanco Animal Health
    A Division of Eli Lilly and Company
    Indianapolis, IN 46285, USA

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  • Principal Display Panel – 100 mL Bottle Label

    ELANCO™ AH 0205

    For Use In Cattle and Swine Only

    Tylan® 50

    Tylosin

    Injection

    50 mg per mL TM

    100 mL

    Principal Display Panel – 100 mL Bottle Label
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  • Principal Display Panel – 100 mL Carton Label

    ELANCO™ AH 0205

    For Use In Cattle and Swine Only

    Tylan® 50

    Tylosin

    Injection

    50 mg per mL TM

    The Original Tylan 50

    An Antibiotic For

    Cattle

    • Pneumonia
    • Shipping
      Fever
    • Metritis
    • Diphtheria
    • Foot Rot

    Swine

    • Pneumonia
    • Mycoplasmal
      Arthritis
    • Dysentery
    • Erysipelas

    100 mL

    Principal Display Panel – 100 mL Carton Label
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  • INGREDIENTS AND APPEARANCE
    TYLAN 50 
    tylosin injection, solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:0986-0205
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TYLOSIN (TYLOSIN) TYLOSIN 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL  
    BENZYL ALCOHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0986-0205-11 1 in 1 CARTON
    1 100 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA012965 07/01/2013
    Labeler - Elanco Animal Health Co (807447169)
    Establishment
    Name Address ID/FEI Business Operations
    Norbrook Laboratories Limited 232880554 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Evonik Degussa Corporation 130890994 API MANUFACTURE
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