Animal NDC 13985-578-16 Neomycin

Neomycin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 13985-578-16
Proprietary Name Neomycin 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 Sulfate 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 Mwi Veterinary Supply, Inc.
Product Type Prescription Animal Drug
Usage Information
    AntibacterialNot For Use in HumansKeep Out of Reach of ChildrenRestricted Drug - Use Only as Directed (California)For Oral Use in Animals OnlyApproved by FDA under ANADA # 200-379CAUTION: 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.
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.

Neomycin 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

Not For Use in Humans

Keep Out of Reach of Children

Restricted Drug - Use Only as Directed (California)

For Oral Use in Animals Only

Approved by FDA under ANADA # 200-379

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).


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