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Animal NDC 46066-211-05 Neovet

Neomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-211-05
Proprietary Name Neovet What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Neomycin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Aspen Veterinary Resources, Ltd.
Product Type Prescription Animal Drug
Usage Information
    Antibacterial - Neomycin SulfateOral Solution for Cattle, Swine, Sheep and GoatsFor Animal Use OnlyKeep Out of Reach of ChildrenCAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.Approved by FDA under ANADA # 200-379INDICATIONS: Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.  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.
Active Ingredient(s)
  • Neomycin Sulfate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200379 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

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Neovet Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Indications & Usage



Antibacterial - Neomycin Sulfate

Oral Solution for Cattle, Swine, Sheep and Goats

For Animal Use Only

Keep Out of Reach of Children

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

Approved by FDA under ANADA # 200-379

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


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:

                                                               Amount of Neomycin Solution
Pounds of body weightPer 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

USE DIRECTION: Teaspoon = U.S. Standard Measure

Neomycin Solution may be given undiluted or diluted with water.

Herd Treatment: Each bottle will treat 76,800 pounds body weight.  Therefore, estimate the total number of pounds body weight of the animals to be treate3d 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 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 consumed in 12-24 hours.


Residue Warning



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 or age or older.

Use of more than one product containing neomycin or failure to sollow withdrawal times may result in illegal drug residues.

RESTRICTED DRUG-USE ONLY AS DIRECTED (CALIFORNIA) FOR ORAL USE IN ANIMALS ONLY.


Contains Per Ml:



neomycin sulfate (commercial grade) 200 mg equivalent to 140 mg neomycin.

IMPORTANT: Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed to 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.


Storage



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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.