Animal NDC 86136-110-47 Sulfadimethoxine Concentrated Solution 12.5%

Animal Product Information

Field Name	Field Value
Animal NDC Code	86136-110-47
Proprietary Name	Sulfadimethoxine Concentrated Solution 12.5% 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	Sulfadimethoxine Concentrated Solution 12.5% 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 Animal Helath
Product Type	Prescription Animal Drug
Usage Information	BROILER AND REPLACEMENT CHICKENS: Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.MEAT PRODUCING TURKEYS: Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE: Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine, calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.
Active Ingredient(s)	Sulfadimethoxine
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	ANADA200165 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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Sulfadimethoxine Concentrated Solution 12.5% Animal Product Labeling Information

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NDC: 86136-110-47

Sulfadimethoxine Concentrated Solution 12.5%

ANTIBACTERIAL

for Use in Drinking Water

For Oral Use in Chickens, Turkeys, and Cattle

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

Approved by FDA under ANADA # 200-165

PROTECT FROM LIGHT

NET CONTENTS: 1 Gallon (3.785 L)

Indications

BROILER AND REPLACEMENT CHICKENS: Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

MEAT PRODUCING TURKEYS: Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE: Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine, calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Precautions

Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59° to 86°F). If freezing occurs, thaw before using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily.

CHICKENS AND TURKEYS: If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication.

Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

CATTLE: During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

FOR USE IN ANIMALS ONLY

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Residue Warnings

Chickens and Turkeys – Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.

Cattle – Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only.

A withdrawal period has not been established for this product in pre-ruminating calves.

Do Not Use in Calves to be Processed for Veal

Restricted Drug (California) – Use Only as Directed

DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT

Dosage And Administration

Chickens and Turkeys
Treatment Period: 6 consecutive days
Recommended Concentrations: Chickens – 0.05%; Turkeys – 0.025%

Chickens		Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water.

Turkeys		Add 1 fl oz (30 mL) to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water.

Automatic Proportioners* Stock Solution		To make 2 gallons of Stock Solution use:

Chickens		Add 1 gallon of Sulfadimethoxine Concentrated Solution 12.5% to 1 gallon of water

Turkeys		Add 2 qts of Sulfadimethoxine Concentrated Solution 12.5% to 6 qts of water

*Set proportioner to a feed rate of 1 fl oz (30 mL) of Sulfadimethoxine Stock Solution per gallon of water.

Dairy Calves, Dairy Heifers, and Beef Cattle
Treatment Period: 5 consecutive days
Dosage: Initial dose of 25 mg/lb followed by four maintenance doses of 12.5 mg/lb/day
Summer Administration

Dosage recommendations for summer are based on an estimated water intake of 1 gallon of water per every 100 lb of body weight per day.

	Sulfadimethoxine Concentrated Solution 12.5%

Daily Drinking Water Supply	Initial Dose		Maintenance Dose

25 gal	1 pt (16 fl oz)		1 cup (8 fl oz)

50 gal	1 qt (32 fl oz)		1 pt (16 fl oz)

200 gal	1 gal (128 fl oz)		2 qt (64 fl oz)

Winter Administration

Dosage recommendations for winter are based on an estimated water intake of 1 gallon of water per every 150 lb of body weight per day.

	Sulfadimethoxine Concentrated Solution 12.5%

Daily Drinking Water Supply	Initial Dose		Maintenance Dose

16 gal	1 pt (16 fl oz)		1 cup (8 fl oz)

33 gal	1 qt (32 fl oz)		1 pt (16 fl oz)

127 gal	1 gal (128 fl oz)		2 qt (64 fl oz)

For individual treatment of cattle, Sulfadimethoxine Concentrated Solution 12.5% may be given as a drench. Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicate one 150-lb animal initially and 1/2 fl oz will medicate one 150-lb animal on maintenance dose.

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

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