Label: NEOSOL- neomycin sulfate powder, for solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated April 24, 2024

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  • DESCRIPTION

    (neomycin sulfate)

    Antibacterial

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

    Approved by FDA under ANADA # 200-235

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

    Net Weight: 50 lb. (22.6 kg) - - Each pound contains: 325 gm neomycin sulfate equivalent to 227.5 gm neomycin.

    Restricted Drug – Use only as Directed (California)

    For Oral Use in Animals Only - Add to drinking water – Not for use in liquid supplements

  • DOSAGE AND ADMINISTRATION:

    Net Weight 50 lb.  (22.6kg) Container:

    Administer 10 mg neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Using measuring spoons, the recommended dosage can be determined as follows:

    Daily Schedule for Drinking Water

    SWINE

    One tablespoonful* of Neosol

    Solubel Powder added to water

    consumed in one day will treat

     Weight of each pig

    50 pigs 

    10 pounds

    20 pigs

    25 pounds 

    10 pigs

    50 pounds 

    CATTLE (Not to be used in veal calves)

    One tablespoonful* of Neosol
    Solubel Powder added to water or
     milk consumed in one day will treat

     Weight of calf

      10 calves

      50 pounds

     7calves 

      75 pounds 

    4 calves 

    125 pounds 

    * Level Tablespoonful = US Standard Measure

    The product should be added to the amount of drinking water estimated 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. For a stock solution, add six level tablespoonfuls to one gallon of water. Each pint of this stock solution will medicate 5 gallons of drinking water. For use in Automatic Proportioners delivering 2 ounces of stock solution per gallon of drinking water, dissolve 9 level tablespoonfuls in a gallon of water to make the stock solution.

    Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.

  • PRECAUTIONS

    CAUTION: 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.  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.

  • WARNINGS AND PRECAUTIONS

    WARNINGS:

    Not for Use in Humans. Keep out of reach of children.

    Residue Warnings: Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:

    Cattle...........................1 day

    Swine and goats............3 days

    Sheep..........................2 days

    A withdrawal period has not been established for this product in pre-rumination 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 residue.

  • STORAGE AND HANDLING

    STORAGE:

    Store in a dry place. When storing partially used containers, securely close bags to prevent contents from caking.

    KEEP CONTAINER TIGHTLY CLOSED - - STORE AT ROOM TEMPERATURE

    CONTACT INFORMATION:

    To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

    Manufactured by:
    Med-Pharmex, Inc.
    Pomona, CA 91767

    Rev. April 2024

  • PRINCIPAL DISPLAY PANEL

    MPX Neosol Powder - 50 lbs - Container Label

  • INGREDIENTS AND APPEARANCE
    NEOSOL 
    neomycin sulfate powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54925-036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN50 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54925-036-5022600 g in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20023503/09/1998
    Labeler - Med-Pharmex, Inc (025353699)