DI-METHOX- sulfadimethoxine powder, for solution

DI-METHOX by

Drug Labeling and Warnings

DI-METHOX by is a Animal medication manufactured, distributed, or labeled by Agri Laboratories, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

ANTIBACTERIAL SOLUBLE POWDER

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

Each packet contains 3.34 oz. (94.6 g) Sulfadimethxine in the form of the soluble salt and disodium edetate.

ANADA 200-031, Approved by the FDA

FOR ANIMAL USE ONLY

NOT FOR HUMAN USE

KEEP OUT OF REACH OF CHILDREN

Restricted Durg-Use Only as Directed (California)

INDICATIONS

FOR BROILER AND REPLACEMENT CHICKENS ONLY-Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infection coryza.

FOR MEAT PRODUCTIN TURKEYS ONLY-Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

FOR DAIRY CLAVES, DAIRY HEIFERS AND BEEF CATTLE-Use for the treatment of shipping fever complex and baterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethxoine; and calf dyphtheria and foot rot associated with Sphaerophorus necrophorus senstivie to sulfadimethoxine.

DOSAGE AND ADMINISTRATION

Species	Concentration	Use Directions
CHICKENS	0.05%	Contents of packet to 50 gallons of water
TURKEYS	0.025%	Contents of packet to 100 gallons of water
Automatic proportioners – To make stock solution, add contents of 5 packets to 2 gallons of water or chickens and to 4 gallons of water for turkeys.  Set proportioner to feed at rate of 1 fl. oz. of stock solution per gallon of water.                                                                              TREATMENT PERIOD - 6 consecutive days
DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE	Dosage: 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days.	Amount of Stock Solution for Cattle*	DI-METHOX IN WATER WATER COMSUMPTION
			(Summer) 1 gallon/** 100 lb b.w.	(Winter) 1 gallon/** 150 lb b.w.
*NOTE:  Make a cattle stock solution by adding 1 packet of DI-METHOX Soluble Powder to 1 gallon of water.	FIRST DAY ADD:	1 quart 2 quart 1 gallon	10 gallons 20 gallons 40 gallons	7 gallons 14 gallons 28 gallons
	NEXT 4 DAYS ADD:	1 quart 2 quart 1 gallon	20 gallons 40 gallons 80 gallons	14 gallons 28 gallons 56 gallons
**This dosage recommendation is based on water consumption of 1 gallon per 100 pounds of body weight per day, the expected water consumption rate for summer.  Water consumption during cold months (winter) may drop markedly (30-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake. For treatment of individual cattle, DI-METHOX Soluble Powder stock solution for cattle may be given as a drench. Administer using same mg/lb dosage as outlined above. Twenty fluid ounces of cattle stock solution will medicate one-600 lb animal initially or two 600 lb animals on maintenance dose. Contents of packet will medicate six-600 lb animals initially or twelve-600 lb animals on maintenance dose.                                                                           TREATMENT PERIOD – 5 consecutive days

CAUTION

CHICKENS AND TURKEYS - If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis.  Prepare a fresh stock solution daily.  Handle the recommended dilutions (chicken 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 and 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.

STORAGE AND HANDLING

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

WARNING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DI-METHOX 
sulfadimethoxine powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 57561-532
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFADIMETHOXINE SODIUM (UNII: 49DG2B481W) (SULFADIMETHOXINE - UNII:30CPC5LDEX)	SULFADIMETHOXINE SODIUM	94.6 g  in 107 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57561-532-01	107 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200031	06/12/2014

Labeler - Agri Laboratories, Ltd (155594450)