Label: NEOMYCIN- neomycin sulfate liquid

  • NDC Code(s): 13985-578-01, 13985-578-16
  • Packager: MWI Veterinary Supply, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated January 9, 2018

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

  • INDICATIONS & USAGE

    Antibacterial

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    Restricted Drug - Use Only as Directed (California)

    For Oral Use in Animals Only.

    ANADA 200-379, Approved by F.D.A.

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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

  • COMPONENTS

    Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycin

  • 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 or diluted with water.

    Herd Treatment: Each bottle will treat 9,600 pounds body weight. Therefore, estimate the total number of pounds body weight of the animals to be treated and administer 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 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.

    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.

  • 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.

  • 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 no use in claves to be processed for veal.

    A milk discard period has not been established for this product in lactating dairy cattle. Do no 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.

  • STORAGE AND HANDLING

    Store at controlled room temperature 20° to 25°C (68° to 77°F)

    (see USP).

  • PRINCIPAL DISPLAY PANEL

    V1-Neomycin Label

  • INGREDIENTS AND APPEARANCE
    NEOMYCIN 
    neomycin sulfate liquid
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-578
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN200 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-578-16473 mL in 1 BOTTLE
    2NDC:13985-578-013785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20037906/02/2014
    Labeler - MWI Veterinary Supply, Inc. (019926120)