Label: NEOMYCIN - neomycin sulfate liquid

  • NDC Code(s): 58005-105-05, 58005-105-07
  • Packager: Sparhawk Laboratories, Inc.
  • Category: OTC 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 12/14

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

  • INDICATIONS & USAGE

    Antibacterial

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.

    Contains per mL: neomycin sulfate 200 mg equivalent to 240 mg neomycin.

    Restricted Drug-Use As Directed (California)

    For Oral Use in Animals Only

    ANADA#: 200-379 Approved by F.D.A.

    Dosage and Administration

    Administer to cattle, swine sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days.

    Dosage Schedule for treatment of colibacillosis:


              Pounds of                         Amount of Neomycin Liquid
            Body Weight                        Per Day in Divided Doses    

                 25 lbs                                  1/4 teaspoonful
                 50 lbs                                  1/2 teaspoonful
               100 lbs                                  1 teaspoonful
               300 lbs                                  1 tablespoonful
               600 lbs                                  1 fluid ounce

    Teaspoon = U.S. Standard Measure

    Neomycin Liquid may be given undiluted with water.

    Herd Treatment: Each bottle will treat 9,600 pounds body weight. Therefore, estimate the total number pounds body weight of the animals to be treated and ad minister one (1) fluid ounce for each 600 pounds. The product should be added to the amount of drinking water to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.

    Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) teaspoon in water or milk for each 100 pounds body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.


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  • Precautions

    To administer the stated dosage, the concentration of neomycin required in medicated water must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption.

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  • ASK DOCTOR

    If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. If symptoms such as fever, depression, or going off feed develop, oral neomycin is not indicated as the sole treatment since systemic levels of neomycin are not obtained due to low absorption from the gastrointestinal tract.

    Important: Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Animals not drinking or eating should be treated individually by drench.

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  • Important

    Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Animals not drinking or eating should be treated individually by drench.

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  • Residue Warnings

    Not for human use.  Keep out of reach of children. Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:

                        Cattle................................................................................. 1 day
                        Sheep................................................................................ 2 days
                        Swine and Goats................................................................ 3 days

    A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
    A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.
    Use of more than one product containing Neomycin or failure to follow withdrawal times may result in illegal drug residues.

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  • STORAGE AND HANDLING

    Store at controlled room temperature 20o to 25oC (68 to 77oF) (see USP).

    TAKE TIME OBSERVE LABEL DIRECTIONS

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  • INGREDIENTS AND APPEARANCE
    NEOMYCIN 
    neomycin liquid
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58005-105
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 140 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58005-105-05 473 mL in 1 BOTTLE
    2 NDC:58005-105-07 3823 mL in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200379 07/31/2007
    Labeler - Sparhawk Laboratories, Inc. (147979082)
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