Label: NEOMYCIN - neomycin sulfate liquid 

  • Label RSS
  • NDC Code(s): 57561-105-05, 57561-105-07
  • Packager: Agri Laboratories, Ltd.
  • 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 01/13

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

  • INDICATIONS


    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.
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  • DOSAGE AND ADMINISTRATION

    Administer to cattle (excluding veal calves), 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 Oral
      Body Weight                Solution Per Day in Divided Doses 
         25 lbs                                   1.2 mL (1/4 tsp*)
         50 lbs                                   2.5 mL (1/2 tsp*)
       100 lbs                                      5 mL (1 tsp*)
       300 lbs                                    15 mL (1 tbsp*)
    591.5 lbs                                   29.5 mL (1 fl oz)
    Neomycin Solution may be given undiluted or diluted with water.

    Herd Treatment: Each 473.1 mL (1 pt) will treat 9,464 pounds of body weight.  Therefore, estimate the total number of pounds body weight of the animals to be treated and administer 29.5 mL (1 fl oz) for 591.5 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 5 mL (1 tsp*) in water or milk for each 100 pounds of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.

    * Teaspoon (tsp) / Tablespoon (tbsp) is equal to U.S. Standard Measure.

    COMPOSITION

    Each mL contains:
    Neomycin Sulfate ........ 200 mg (equivalent to 140 mg neomycin base)

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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.

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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.
    Restricted Drug - Use Only As Directed (California)

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  • RESIDUE WARNINGS

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

    Cattle................................................................................. 1 day
    (not to be used in veal calves)
    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 (68o to 77oF)

    TAKE TIME OBSERVE LABEL DIRECTIONS

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  • PRINCIPAL DISPLAY PANEL


    Antibacterial

    For Oral Use Only

    For Animal Use Only

    Keep Out of Reach of Children

    ANADA 200-379, Approved by FDA

    AL-Neomycin Oral label
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  • INGREDIENTS AND APPEARANCE
    NEOMYCIN 
    neomycin liquid
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:57561-105
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (Neomycin) Neomycin 140 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57561-105-05 473 mL in 1 BOTTLE
    2 NDC:57561-105-07 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 - Agri Laboratories, Ltd. (155594450)
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