Label: SULFASOL - sulfadimethoxine sodium powder, for solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated March 23, 2017

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  • INDICATIONS & USAGE

    SULFASOL
    SOLUBLE POWDER
    Antibacterial
    (Brand of Sulfadimethoxine)

    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) 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

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  • DOSAGE & ADMINISTRATION

    SULFADIMETHOXINE

    SOLUBLE POWDER

    Dosage and Administration:

    Species

    Concentration

    Use of Directions

    Chickens

    0.05%

    Contents of packet 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 Calves, Dairy Heifers, and Beef Cattle

    Dosage: 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days

    Sulfadimethoxine in Water

    Water Consumption

    Amount of Stock Solution

    for Cattle*

    (Summer)*

    1 gal/100 lb body weight**

    (Winter)*

    1 gal/150 lb body weight**

    First Day Add

    1 qt

    10 gal

    7 gal

    2 qt

    20 gal

    14 gal

    1 gal

    40 gal

    28 gal

    Next 4 Days Add

    1 qt

    20 gal

    14 gal

    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 of 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

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  • WARNINGS AND PRECAUTIONS

    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

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  • INGREDIENTS AND APPEARANCE
    SULFASOL  
    sulfadimethoxine sodium powder, for solution
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54925-035
    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:54925-035-37 107 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200238 07/28/1998
    Labeler - Med-Pharmex, Inc (025353699)
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