Label: AUREOMYCIN- chlortetracycline hydrochloride granule

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

Drug Label Information

Updated May 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Aureomycin®

    90 Granular

    Chlortetracycline
    Type A Medicated Article

  • Active drug ingredient

    Chlortetracycline calcium complex equivalent to 90 g chlortetracycline hydrochloride per lb.

  • Ingredients

    Dried Streptomyces aureofaciens Fermentation Product and Calcium Sulfate.

  • PURPOSE

    For use in the manufacture of medicated animal feeds.
    For use in dry feed only. Not for use in liquid medicated feeds.

  • Use directions

    Mix sufficient Aureomycin 90 Granular Type A Medicated Article to supply desired concentration of chlortetracycline per ton with part of the feed ingredients to make a preblend. Add the remainder of the ingredients and mix thoroughly. For specific use levels, see Indications for use.

  • Mixing directions

    Level desired grams per tonAmount of medicated article per ton †

    50

    9 oz

    100

    1 lb 2 oz

    200

    2 lb 4 oz

    400

    4 lb 8 oz

    500

    5 lb 9 oz

    † It is recommended that 1 pound 2 ounces of Aureomycin 90 Granular Type A Medicated Article be diluted with 2 pounds 14 ounces of one of the feed ingredients to form a 4 pound working premix. Use 2 pounds of the working premix to make a preblend (see Use directions) for a Type C feed containing 50 g chlortetracycline / ton of feed

  • Indications for use

    Indications for use Chlortetracycline
    mg per lb body
    wt per day
    Cattle 
    Beef Cattle (over 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. 0.5
        
    Beef and Non-Lactating Dairy Cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. For use in free-choice feeds.  A  medicated feed mill license is required when the  free-choice feed is manufactured using a  proprietary formula and/or specifications.  Free-choice feed formulations must be  FDA-approved. 0.5-2.0
        
    Calves, Beef and Non-Lactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Feed for not more than 5 days. The appropriate amount of Aureomycin-containing feed supplement may be mixed in the cattle's daily ration or administered as a top-dress. If the Aureomycin-containing feed supplement is administered as a top-dress, it must be spread uniformly on top of the ration and sufficient space must be provided so that all cattle can eat at the same time. 10
      
    Swine 
    Control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.
    Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
    (Note: this drug level is equivalent to approximately 400 grams per ton, depending on feed consumption and body weight.)
    Feed for not more than 14 days.
     10
      
    Turkeys 
    Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 days. 25
      
    Indications for use mg per head
    per day
    Cattle 
    Growing Cattle (over 400 lb): For the reduction of the incidence of  liver abscesses. 70
        
    Beef Cattle and Dairy Replacement Heifers: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. 350
        
    Beef Cattle (under 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. 350
      
    Sheep 
    Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline. 80
      
    Indications for use In complete feed Chlortetracycline g per ton
    Swine 
    Reduction in the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline. 50-100
        
    Breeding Swine: Control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days. 400
      
    Ducks 
    Control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. Feed in complete ration to provide from 8 to 28 mg per pound of body weight per day depending upon age and severity of disease. Feed for not more than 21 days. 200-400
      
    Chickens 
    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.
    Feed continuously for 7 to 14 days.
     100-200
        
    Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.
    Feed continuously for 7 to 14 days.
     200-400
        
    Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline. Feed for 5 days. 500
      
    Turkeys 
    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days. 200
        
    Control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. Feed continuously for 7 to 14 days. 400
        
    Turkey Poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. 400
      
    Indications for use mg per g feed
    Psittacine birds 
    Warning: Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals and man. Contact appropriate public health and regulatory officials. 
    Caution: Aspergilliosis may occur following prolonged treatment. 
        
    Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume an amount of medicated feed equal to one-fifth of its body weight daily. During treatment, parrots, macaws, and cockatoos should be kept individually or in pairs in clean cages. 10
  • Withdrawal Periods and Residue Warnings

    No withdrawal period is required when used according to labeling. This drug 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to ducks or turkeys producing eggs for human consumption.

  • Storage

    Store below 25°C (77°F), excursions permitted to 37°C (99°F)
    Restricted Drug (California) - Use only as directed. Not for use in humans. Keep out of reach of children.
    Approved by FDA under NADA # 048-761

  • SPL UNCLASSIFIED SECTION

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    40025773

    Take time Observe label directions image
  • PRINCIPAL DISPLAY PANEL

    40041436

    90 Granular Bag Label

  • INGREDIENTS AND APPEARANCE
    AUREOMYCIN 
    chlortetracycline hydrochloride granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:54771-1005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORTETRACYCLINE HYDROCHLORIDE (UNII: O1GX33ON8R) (CHLORTETRACYCLINE - UNII:WCK1KIQ23Q) CHLORTETRACYCLINE HYDROCHLORIDE90 g  in 0.45 kg
    Product Characteristics
    Colorgray (gray to brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1005-022.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA04876101/01/2009
    Labeler - Zoetis Inc. (828851555)