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SULFASOL

Med-Pharmex, Inc

SULFASOL SOLUBLE POWDER




FULL PRESCRIBING INFORMATION

Uses

SULFASOL
SOLUBLE POWDER
Antibacterial
(Brand of Sulfadimethoxine)

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

Restricted Drug (California) - Use Only as Directed.
Not for Human Use.

For Broiler and Replacement Chickens Only - Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

For Meat-producing Turkeys Only - Use for the treatment of disease outbreaks of coccidiosis, and fowl cholera.

For 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; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

Net Wt.: 3.77 oz (107g)

MED-PHARMEX
INCORPORATED
Pomona, CA 91767

ANADA #200-238
APPROVED BY FDA


                                                                SULFADIMETHOXINE
                                                                                        SOLUBLE POWDER
Dosage and Administration:
          Species                Concentration                Use of Directions
              Chickens                          0.05%                                 Contents of package to 50 gal of water
              Turkeys                            0.025%                               Contents of packet to 100 gal of water
Automatic Proportioners: To make stock solution, add contents of 5 packets to 2 gal of water for chickens and to 4 gal of water for turkeys.
Set proportioner to feed at a rate of  1 fl oz stock solution per gal of water.
Treatment Period: 6 consecutive days
Dairy Calver, Dairy Heifers, and Beef Cattle
Dosage: 25 mg/lb first day following 12.5 mg/lb/day for 4 days
                                                             Sulfadimethoxine In Water
                                                                 Water Consumption
                              Amount of Stock Solution               (Summer)*                                       (Winter)*  
                                    for Cattle*                             1 gal/100 lb body weight**           1 gal/150 lb body weight**
                                           1 qt                                                  10 gal                                           7 gal
     First Day Add           2 qt                                                  20 gal                                           14 gal
                                           1 gal                                                40 gal                                           28 gal
                                           1 qt                                                  20 gal                                           14 gal
     Next 4 Days Add    2 qt                                                  40 gal                                           28 gal
                                           1 gal                                                80 gal                                            56 gal                                    
*Note: Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gal of water.
*Twenty fl oz cattle stock solution will medicate 1-600 lb animal initially or 2-600 lb animals on maintenance dose.  Contents of packet will medicate
6-600 lb animals initially or 12-600 lb animals on maintenance dose.
** This dosage recommendation is based on a water consumption of 1 gal per 100 lb 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, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench.
Treatment Period: 5 consecutive days

Caution: Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily.  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, reevaluate diagnosis. Treatment should not be continued beyond 5 days.

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


SULFASOL

SULFASOL

SULFADIMETHOXINE SODIUM POWDER, FOR SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:54925-035
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Sulfadimethoxine Sodium SULFADIMETHOXINE 94.6 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54925-035-37 107 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200238 1998-07-28


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