Animal NDC 57561-532-01 Di-methox

Sulfadimethoxine

Animal NDC Product Code 57561-532-01

Field Name Field Value
Animal NDC Code 57561-532-01
Proprietary Name Di-methox 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 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 Agri Laboratories, Ltd
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Sulfadimethoxine Sodium
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 ANADA200031 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.

Di-methox Animal Product Label Images

Di-methox 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.

Product Labeling Index

Indications & Usage

ANTIBACTERIAL SOLUBLE POWDERCAUTION: 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 FDAFOR ANIMAL USE ONLYNOT FOR HUMAN USEKEEP OUT OF REACH OF CHILDRENRestricted Durg-Use Only as Directed (California)INDICATIONSFOR 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

SpeciesConcentrationUse DirectionsCHICKENS0.05%Contents of packet to 50 gallons of waterTURKEYS0.025%Contents of packet to 100 gallons of waterAutomatic 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 daysDAIRY CALVES, DAIRYHEIFERS AND BEEF CATTLEDosage:25 mg/lb first day followed by12.5 mg/lb/day for4 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 stocksolution by adding1 packet ofDI-METHOXSoluble Powder to1 gallon of water.FIRST DAY ADD:1 quart2 quart1 gallon10 gallons20 gallons40 gallons7 gallons14 gallons28 gallonsNEXT 4 DAYS ADD:1 quart2 quart1 gallon20 gallons40 gallons80 gallons14 gallons28 gallons56 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.

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