TYLAN 40 SULFA-G (TYLOSIN PHOSPHATE AND SULFAMETHAZINE) GRANULE [ELANCO]

TYLAN 40 SULFA-G (TYLOSIN PHOSPHATE AND SULFAMETHAZINE) GRANULE [ELANCO]
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NDC 58198-0904-1
Set ID 744d929d-3081-4d54-a853-4a296daceb35
Category VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager Elanco US Inc.
Generic Name
Product Class
Product Number
Application Number NADA041275
  • SPL UNCLASSIFIED SECTION

    AF0904
    Elanco
    Tylan™40 Sulfa-G™

    Net Weight 50 lbs (22.68 kg)

    Tylosin Phosphate and Sulfamethazine Elliptical Pellets

    Type A Medicated Article

    CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

    For Use in Swine Feeds Only

    Do not feed undiluted.

    Equivalent to 40 g tylosin per pound and 40 g sulfamethazine per pound.

    For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci.

    Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.

    Restricted Drug (California) - Use only as directed.

    NADA 041-275, Approved by the FDA.

    Manufactured for:

    Elanco US Inc.

    2500 Innovation Way

    Greenfield, IN 46140, USA

  • QUESTIONS

    Questions or Comments Call 1-800-428-4441

    Elanco, Tylan, Sulfa-G and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

    BG091003AMX

  • SPL UNCLASSIFIED SECTION

    AF0904

    Elanco™

    Tylan™ 40 Sulfa-G™

    Tylosin Phosphate and Sulfamethazine Elliptical Pellets

    Net Weight 50 lbs (22.68 kg)

    Type A Medicated Article

    For Use in Swine Feeds Only

    Do not feed undiluted.

  • Active Drug Ingredients:

    Tylosin (as tylosin phosphate) ................................40 g per lb

    Sulfamethazine...................................................... 8.8% (40 g per lb)

  • SPL UNCLASSIFIED SECTION

    Ingredients: Roughage products, calcium carbonate, and mineral oil.

    Caution: Do not use in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite.

  • WARNINGS

    Warning: Tylan 40 Sulfa-G may be irritating to unprotected skin and eyes. When mixing and handling Tylan 40 Sulfa-G use protective clothing and impervious gloves. 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 in users or obtain a copy of the MSDS, call 1-800-428-4441.

    For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.

    Mixing and Feeding Directions: Thoroughly mix 2.5 pounds Tylan 40 Sulfa-G in one ton of Type C Feed to provide 100 grams of tylosin and 100 grams of sulfamethazine per ton.

    NOT FOR HUMAN USE.

    WARNING: Feeds containing Tylan 40 Sulfa-G must be withdrawn 15 days before swine are slaughtered.

    Store at or below 25° C (77° F). Excursions permitted to 37° C (99° F). Avoid Moisture.

    Not to be used after the date printed on bag.

    Logo

  • Principal Display Panel - Tylan 40 Sulfa-G Bag Label

    Elanco™

    AF0904

    Tylan™ 40 Sulfa-G™

    Net Weight 50 lbs
    (22.68 kg)

    Principal Display Panel - Tylan 40 Sulfa-G Bag Label
  • INGREDIENTS AND APPEARANCE
    TYLAN 40 SULFA-G 
    tylosin phosphate and sulfamethazine granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-0904
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    tylosin phosphate (UNII: NR75X12AFF) (tylosin - UNII:YEF4JXN031) tylosin phosphate88 g  in 1 kg
    sulfamethazine (UNII: 48U51W007F) (sulfamethazine - UNII:48U51W007F) sulfamethazine88 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    mineral oil (UNII: T5L8T28FGP)  
    rice bran (UNII: R60QEP13IC)  
    calcium carbonate (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0904-122.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA04127510/18/2010
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elanco Clinton Laboratories 039138631API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Provimi North America, Inc.027859585MANUFACTURE, LABEL, PACK

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