Animal NDC 61133-5442-3 Neomed 325

Neomycin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-5442-3
Proprietary Name Neomed 325 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 Bimeda, Inc.
Product Type Prescription Animal Drug
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 ANADA200050 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.

Neomed 325 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



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)

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)

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)

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.

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).


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).


Package Label.Principal Display Panel




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