Label: NEOMED 325- neomycin sulfate powder, for solution

  • NDC Code(s): 61133-5442-2, 61133-5442-3, 61133-5442-4
  • Packager: Bimeda, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated March 28, 2024

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  • 100 g pouch

    NeoMed® 325
    (neomycin sulfate)
    Soluble Powder (Commercial Grade)
    FOR ORAL USE IN CATTLE, SWINE, SHEEP, GOATS & TURKEYS

    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.
    For the control of mortality associated with Escherichia coli organisms susceptible to neomycin sulfate in growing turkeys.
    Antibacterial

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

    Each Packet Contains: 71.4 g neomycin sulfate (commercial grade) equivalent to 50 g neomycin.

    NOT FOR USE IN HUMANS
    KEEP OUT OF REACH OF CHILDREN
    Restricted Drug (California)- Use Only as Directed

    Approved by FDA under ANADA # 200-050

    NET WEIGHT:
    100 g (3.5 oz)

  • 100 g pouch

    Add to drinking water - Not for use in liquid supplements.

    DOSAGE AND ADMINISTRATION: Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg of neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Administer to turkeys at a dose of 10 mg neomycin sulfate per pound of body weight per day for 5 days.

    Herd/Flock Treatment: Each packet will treat 7,150 pounds body weight. Therefore, estimate the total number of pounds of body weight of the animals to be treated and administer one (1) packet (or portion thereof) for each 7,150 pounds. 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.

    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 of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.

    Drinking Water: Swine Use the number of packets indicated below in 256 gallons of water, or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.

     Pigs Weighing 25 to 50 Pounds 2 Packets
     Pigs Weighing 50 to 100 Pounds 3 Packets
     Pigs Weighing Over 100 Pounds 4 Packets

  • 200 g Pouch

    NeoMed® 325
    (neomycin sulfate)
    Soluble Powder (Commercial Grade)
    FOR ORAL USE IN CATTLE, SWINE, SHEEP, GOATS & TURKEYS

    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.
    For the control of mortality associated with Escherichia coli organisms susceptible to neomycin sulfate in growing turkeys.
    Antibacterial

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

    Each Packet Contains: 142.8 g neomycin sulfate (commercial grade) equivalent to 100 g neomycin.

    NOT FOR USE IN HUMANS
    KEEP OUT OF REACH OF CHILDREN
    Restricted Drug (California)- Use Only as Directed

    Approved by FDA under ANADA # 200-050

    NET WEIGHT:
    200 g (7 oz)

  • 200 g Pouch

    Add to drinking water - Not for use in liquid supplements.
    DOSAGE AND ADMINISTRATION: Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg of neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Administer to turkeys at a dose of 10 mg neomycin sulfate per pound of body weight per day for 5 days.
    Herd/Flock Treatment: Each packet will treat 14,300 pounds body weight. Therefore, estimate the total number of pounds of body weight of the animals to be treated and administer one (1) packet (or portion thereof) for each 14,300 pounds. 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.
    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 of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.
    Drinking Water: Swine Use the number of packets indicated below in 256 gallons of water, or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.

     Pigs Weighing 25-50 Pounds 1 Packet
     Pigs Weighing 50 to 100 Pounds 1.5 Packets
     Pigs Weighing Over 100 Pounds 2 Packets

  • 50 Pounds

    NeoMed® 325
    (neomycin sulfate)
    Soluble Powder (Commercial Grade)
    FOR ORAL USE IN CATTLE, SWINE, SHEEP, GOATS & TURKEYS

    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.
    For the control of mortality associated with Escherichia coli organisms susceptible to neomycin sulfate in growing turkeys.
    Antibacterial

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

    Each Pound Contains: 325 g neomycin sulfate (commercial grade) equivalent to 227.5 g neomycin.

    NOT FOR USE IN HUMANS
    KEEP OUT OF REACH OF CHILDREN
    Restricted Drug (California)- Use Only as Directed

    Approved by FDA under ANADA # 200-050

    NET WEIGHT:
    50 Pounds (22.7 kg)

  • 50 Pounds

    Add to drinking water - Not for use in liquid supplements.
    Dosage and Administration:
    Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg of neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. Administer to turkeys at a dose of 10 mg neomycin sulfate per pound of body weight per day for 5 days. Using measuring spoons, the recommended dosage can be determined as follows:

    Daily Schedule For Drinking Water:

    SWINE 
     One level tablespoon of NeoMed 325 added to water consumed in one day will treatWeight of each pig 
     50 pigs 10 pounds
     20 pigs 25 pounds
     10 pigs 50 pounds
    CATTLE 
    One level tablespoon of NeoMed 325 added to water consumed in one day will treatWeight of each calf 
     10 calves 50 pounds
     7 calves 75 pounds
     4 calves 125 pounds
    TURKEYS 
     One level tablespoon of NeoMed 325 added to water consumed in one day will treatWeight of each bird 
     1000 birds 0.5 pounds
     500 birds 1 pounds
     100 birds 5 pounds
     50 birds 10 pounds

    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 tablespoons 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 tablespoons 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 of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.

  • WARNINGS AND 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 for cattle, swine, sheep and goats and 5 days for turkeys. Animals not drinking or eating should be treated individually by drench.

    Warning: Not for human use. Keep out of reach of children.

  • RESIDUE WARNING

    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
     Turkeys 0 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.

    The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • 100 g and 200 g Pouches

    When storing partially used packet, securely close protect from moisture. Store in a dry place.

    Store at controlled room temperature 20°C-25°C (68°F-77°F), with excursions permitted to
    15°C- 30°C (59°-86°F).

  • 50 Pounds

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

    Store at controlled room temperature 20°C-25°C (68°F-77°F), with excursions permitted to
    15°C- 30°C (59°-86°F).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    NEOMED 325 
    neomycin sulfate powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-5442
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin227.5 g  in 0.454 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-5442-222.7 kg in 1 PAIL
    2NDC:61133-5442-30.2 kg in 1 POUCH
    3NDC:61133-5442-40.1 kg in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20005001/12/2010
    Labeler - Bimeda, Inc. (060492923)
    Registrant - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture