Label: DI-METHOX CONCENTRATED SOLUTION 12.5%- sulfadimethoxine concentrated solution 12.5% solution, concentrate

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

Drug Label Information

Updated March 1, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

          NDC 23243-370-07

             DI-METHOX®
          (sulfadimethoxine)
    CONCENTRATED SOLUTION 12.5%

  • WARNINGS AND PRECAUTIONS

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

  • SPL UNCLASSIFIED SECTION

    Antibacterial for use in drinking water

    For Oral Use in Chickens, Turkeys and Cattle

    3.75 g sulfadimethoxine/fl oz

    Protect From Light

    Approved by FDA under ANADA # 200-030

    NET CONTENTS: 3.8 Liters (1 GALLON)

  • VETERINARY INDICATIONS

    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; and calf diphtheria and foot rot associated
    with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to
    sulfadimethoxine.

  • PRECAUTIONS

    PRECAUTION: Store at room temperature; 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.

  • RESIDUE WARNING

    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.

  • STORAGE AND HANDLING

    STORE AT CONTROLLED ROOM TEMPERATURE 20–25°C (68–77°F).

  • USER SAFETY WARNINGS

    NOT FOR USE IN HUMANS
    KEEP OUT OF REACH OF CHILDREN
    Restricted Drug (California) – Use Only as Directed

    To report suspected adverse drug events, for technical assistance or to obtain a copy
    of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
    www.huvepharma.us. For additional information about adverse drug experience
    reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
    http://www.fda.gov/reportanimalae.

  • SPL UNCLASSIFIED SECTION

    S-3369-07
    Rev. 03-2021

    Take Time

    Manufactured for
    Huvepharma, Inc.
    Peachtree City, GA 30269          ® Registered trademark of Huvepharma, Inc.

    LOT NO.:                                     EXP. DATE:

  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Chickens and Turkeys

    Treatment Period: 6 consecutive days

    Recommended Concentration: Chickens–0.05%; Turkeys–0.025%

    Chickens

    Add 1 fl oz (30 mL) to 2 gal of drinking water or

    25 fl oz to 50 gal of drinking water.

    Turkeys

    Add 1 fl oz (30 mL) to 4 gal of drinking water or

    25 fl oz to 100 gal of drinking water.

    Automatic Proportioners*Stock Solution–To make 2 gal of stock solution:

    Chickens

    Add 1 gal of DiMethox® Concentrated Solution 12.5% to 1 gal of water.

    Turkeys

    Add 2 qt of DiMethox® Concentrated Solution 12.5% to 6 qt of water.

    *Set proportioner to a feed rate of 1 fl oz of stock solution per gal 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 gal
       of water for every 100 lb of body weight per day.

    DiMethox® 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 gal
       of water for every 150 lb of body weight per day.

    DiMethox® 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, Di-Methox® 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.

  • PRINCIPAL DISPLAY PANEL

    Di-Methox HVP LabelDi-Methox HVP Label

  • INGREDIENTS AND APPEARANCE
    DI-METHOX CONCENTRATED SOLUTION 12.5% 
    sulfadimethoxine concentrated solution 12.5% solution, concentrate
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:23243-3700
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfadimethoxine (UNII: 30CPC5LDEX) (SULFADIMETHOXINE - UNII:30CPC5LDEX) Sulfadimethoxine3750 mg  in 0.2366 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-3700-73.8 L in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20003002/01/2009
    Labeler - Huvepharma, Inc (619153559)
    Registrant - Huvepharma EOOD (552671651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082manufacture, analysis