NEOMED 325- neomycin sulfate powder, for solution

NeoMed 325 by

Drug Labeling and Warnings

NeoMed 325 by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

NeoMed® 325

(neomycin sulfate) 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

ANADA 200-050, Approved by FDA

NET WEIGHT:

50 Pounds (22.7 kg)

DOSAGE & ADMINISTRATION

For oral use in animals only.

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

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:

• One level tablespoonful* of NeoMed® 325 added to water consumed in one day will treat: Weight of each pig
• 50 pigs: 10 pounds
• 20 pigs: 25 pounds
• 10 pigs: 50 pounds

• One level tablespoonful* of NeoMed® 325 added to water consumed in one day will treat: Weight of each calf
• 10 calves: 50 pounds
• 7 calves: 75 pounds
• 4 calves: 125 pounds

• One level tablespooful* of NeoMed® 325 added to water consumed in one day will treat: Weight of each bird
• 1000 bids: 0.5 pounds
• 500 birds: 1 pounds
• 100 birds: 5 pounds
• 50 birds: 10 pounds

*Level Tablespoonful = US Standard Measure

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).

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 tablespoonfuls* 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 tablespoonfuls* 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 teaspoonful** 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.

**Level teaspoonful=US Standard Measure

PRECAUTIONS

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.

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEOMED 325 
neomycin sulfate powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-5442
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	227.5 g  in 0.454 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-5442-2	22.7 kg in 1 PAIL
2	NDC: 61133-5442-3	0.2 kg in 1 POUCH
3	NDC: 61133-5442-4	0.1 kg in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200050	02/15/1995

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture