Label: PENNCHLOR 64 - chlortetracycline hydrochloride powder 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 05/10

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  • RESIDUE WARNING

    Pennchlor 64 - Chlortetracycline hydrochloride - 102.4 g per packets (64g/lb)

    RESIDUE WARNINGS

    Do not administer to chickens within 24 hours of slaughter.  Do not use in laying chickens.  Do not administer to growing turkeys within 24 hours of slaughter.  Zero day withdrawal in swine.  Do not administer to cattle within 24 hours of slaughter.  Do not use in lactating dairy cattle.  A withdrawal period has not been established in pre-ruminating calves.  Do not use in calves to be processed for veal.


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  • DOSAGE FORMS & STRENGTHS

    General Information on Dosage

    Dosages in terms of packets per 512 gallons are based on stated dosages per unit of body weight and average water consumption of the species.  Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water.  Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.


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  • PRECAUTIONS

    PRECAUTIONS

    Use as the sole source of chlortetracycline.  Prepare fresh solutions daily.  When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours.  When used in galvanized waterers, prepare fresh solutions every 12 hours.  Do not administer in milk or milk replacers.  When feeding milk or milk replacers, administration one hour before or two hours after feeding is recommended.



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  • INDICATIONS & USAGE

    INDICATIONS

    CHICKENS

    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

    Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.

    Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.


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  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE

    DOSE

    200-400 mg/gal (1-2 packets/512 gallons, this is equivalent to 2-4 teaspoons of powder per 5 gallons of water), administer at the indicated rates in the total water consumed over a full, 24-hour period.  Administer 7 to 14 days.

    400-800 mg/gal (2-4 packets/512 gallons, this is equivalent to 4-8 teaspoons of powder per 5 gallons of water), administer at the indicated rates in the total water consumed over a full, 24-hour period.  Administer 7 to 14 days.

    1000 mg/gal (5 packets/512 gallons, this is equivalent to 2 teaspoons of powder per 1 gallon of water), administer at the indicated rates in the total water consumed over a full, 24-hour period.  Administer 7 to 14 days.



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  • INDICATIONS & USAGE

    INDICATIONS

    SWINE

    Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Samonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline. Close
  • INDICATIONS & USAGE

    DIRECTIONS FOR USE

    DOSE - 10 mg/pound body weight daily


    (5 packets/512 gallons will treat 512 100-lb pigs per day, 2 teaspoons of powder will treat a 100 lb. pig for one day).  Administer at this rate in the total water consumed over a full, 24-hour period.  Administer for 3-5 days.
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  • INDICATIONS & USAGE

    INDICATIONS

    CALVES, BEEF CATTLE, AND NON-LACTATING DAIRY CATTLE

    Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline.


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  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE

    DOSE - 10 mg/pound body weight daily

    Use 2 teaspoon of powder for each 100 lbs. of calf weight per day.  Administer at this rate in the total water consumed over a full, 24-hour period, or as a drench in divided doses.  Administer 3 to 5 days.


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  • INDICATIONS & USAGE

    INDICATIONS

    GROWING TURKEYS


    Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

    Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.
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  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE

    DOSE


    400 mg/gal (2 packets/512 gallons, this is equivalent to 4 teaspoons of powder per 5 gallons of water), administer at this rate in the total water consumed over a full, 24-hour period.  Administer 7 to 14 days.

    25 mg/lb body weight/day (1 packet for every 4,096 lbs of turkeys, 1 teaspoon treats a 20 lb. turkey for one day), administer in the total water consumed over a full, 24-hour period.  Administer 7 to 14 days.



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  • GENERAL PRECAUTIONS

    Medicate chickens and turkeys continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days.  The dosage ranges permitted for different levels based on the severity of the infection.  If improvement is not noted in 24-48 hours, consult a veterinarian or a diagnostic laboratory to determine diagnoses and for advice regarding the optimal level of the drug where ranges are permitted.

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  • PRINCIPAL DISPLAY PANEL

    Pennchlor 64
    Chlortetracyline HCI

    SOLUBLE POWDER CONCENTRATE

    Antibiotic
    For Animal Use in Drinking Water

    Chlortetracycline hydrochloride 64 g per pound


    Each packet contains 102.4 g of chlortetracycline HCI and will make:
        1,024 gallons (3,876 L) containing 100 mg Pennchlor 64 chlortetracycline HCI per gallon

        512 gallons (1,938 L) containing 200 mg Pennchlor 64 chlortetracycline HCI per gallon

        256 gallons (969 L) containing 400 mg Pennchlor 64 chlortetracycline HCI per gallon

        102.4 gallons (387 L) containing 1,000 mg Pennchlor 64 chlortetracycline HCI per gallon

            Each teaspoon of Pennchlor 64 powder contains 500 mg of chlortetracycline HCI

    Net Contents:  25.6 oz (725.7 g)

    ANADA 200-295  APPROVED BY FDA
    RESTRICTED DRUG (CA): USE ONLY AS DIRECTED.
    NOT FOR HUMAN USE
    STORE AT CONTROLLED ROOM TEMPERATURE 15 degrees to 30 degrees C (59 degrees to 86 degrees F)


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  • PRINCIPAL DISPLAY PANEL

    image of labelEnter section text here

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  • INGREDIENTS AND APPEARANCE
    PENNCHLOR 64 
    chlortetrcycline hydrochloride powder
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:48164-0026
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlortetracycline Hydrochloride (Chlortetracycline ) Chlortetracycline Hydrochloride 141 g  in 1 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48164-0026-6 141 kg in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200295 04/27/2001
    Labeler - PennField Oil Company (035138569)
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