Label: PEN-AQUEOUS- penicillin g procaine injection, suspension 

  • Label RSS
  • NDC Code(s): 46066-151-01, 46066-151-02, 46066-151-03
  • Packager: Aspen Veterinary Resources
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 09/13

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  • DESCRIPTION

    Pen-Aqueous®

    (penicillin G procaine)

    Injectable Suspension for Cattle, Swine, Sheep & Horses

    Aqueous Suspension

    Antibiotic

    300,000 units per mL

    Restricted Drug (California) - Use Only as Directed

    NADA 065-505, Approved by FDA

    For Intramuscular Use Only

    Sterile, Multiple Dose Vial

    Net Contents: 250 mL

    FOR ANIMAL USE ONLY

    DESCRIPTION: Penicillin G Procaine Injectable Suspension Alternative Method is available in 100-mL, 250-mL and 500-mL multiple-dose vials. Each mL contains: penicillin g potassium 300,000 units*, procaine hydrochloride 130.8 mg*, methylparaben 1.3 mg, propylparaben 0.2 mg, sodium citrate 10 mg, sodium carboxymethylcellulose 1 mg, povidone 5 mg, lecithin 6 mg, sodium formaldehyde sulfoxylate 0.2 mg, procaine hydrochloride 20 mg, and Water for injection, q.s.

    *Penicillin G Potassium and Procaine Hydrochloride react to form Penicillin G Procaine.

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  • MECHANISM OF ACTION

    ACTIONS: Penicillin G is an effective bactericide in the treatment of infections caused primarily by penicillin-sensitive organisms, such as Streptococcus equi and Erysipelothrix thusiopathiae, as well as the gram negative organism Pasteurella multocida.

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  • INDICATIONS & USAGE

    INDICATIONS: Penicillin G Procaine is indicated for the treatment of:

    1. Cattle and sheep - bacterial pneumonia (shipping fever) caused by Pasteurella multocida.

    2. Swine - erysipelas caused by Erysipelothrix rhusiopathiae.

    2. Horses - strangles caused by Streptococcus equi.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE: The suspension should be administered by deep intramuscular injection within the fleshy muscles of the hip, rump, round or thigh, or into the neck, changing the site for each injection. Do not inject subcutaneously, into a blood vessel, or near a major nerve.

    Use a 16 or 18 gauge needle, 1.5 inches long. The needle and syringe should be washed thoroughly before use. The needle and syringe should then be sterilized by placing in boiling water for 15 to 20 minutes. No vial should be entered more than 15 times with a 16 gauge needle or more than 40 times with an 18 gauge needle.

    The injection site should be washed with soap and water and painted with a germicide such as tincture or iodine or 70% alcohol. The product should then be administered by using the following procedure:

    1. Warm the vial to room temperature and shake thoroughly to ensure uniform suspension.

    2. Wipe the rubber stopper on top of the vial with a piece of absorbent cotton soaked in 70% alcohol.

    3. Inject air into the vial for easier withdrawal.

    4. After filling the syringe, make sure the needle is empty by pulling back the plunger of the syringe until a small air bubble appears. Then detach the needle from the syringe.

    5. Insert the needle deep into the muscle, attach the syringe and withdraw the plunger slightly. If blood appears, withdraw the needle and insert into a different location.

    6. Inject the dose slowly. Do not massage the site of injection.

    7. Not more than 10 mL should be injected into one location.

    Daily treatment should be continued for at least 48 hours after temperature has returned to normal and all other signs of infection have subsided. Animals treated with Penicillin G Procaine Injectable Suspension should show noticeable improvement within 36 to 48 hours.

    DOSAGE: The dosage for cattle, sheep, swine, and horses is 3000 units per pound of body weight, or 1.0 mL for each 100 pounds of body weight, once daily. Treatment should not exceed 7 days in non-lactating dairy and beef cattle, sheep, and swine, or 5 days in lactating dairy cattle. If no improvement is observed within 48 hours, consult your veterinarian.

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  • RESIDUE WARNING

    RESIDUE WARNINGS:

    1. Not for use in horses intended for food.

    2. Milk that has been taken from animals during treatment and for 48 hours after the last treatment must not be used for food. The daily treatment schedule should not exceed 7 days of treatment in non-lactating dairy and beef cattle, sheep and swine, or 5 days in lactating dairy cattle.

    3. The drug should be discontinued for the following time periods before treated animals are slaughtered for food: cattle - 4 days; sheep - 8 days; swine - 6 days; non-ruminating calves - 7 days.

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  • PRECAUTIONS

    PRECAUTIONS: Sensitivity reactoins to penicillin and procaine, such as hives or respiratory distress, may occur in some animals. If such signs of sensitivity occur, stop medication and call your veterinarian. In some instances, particularly if respiratory distress is severe, immediate injection of epinephrine or antihistamine may be necessary.

    As with any antibiotic preparation, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If this condition is suspected, stop medication and consult your veterinarian.

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  • HOW SUPPLIED

    HOW SUPPLIED: Penicillin G Procaine Injectable Suspension is supplied in 100-mL, 250-mL, and 500-mL multiple-dose vials.

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  • STORAGE AND HANDLING

    STORE BETWEEN 2°C -8°C (36°F - 46°F). AVOID FREEZING. WARM TO ROOM TEMPERATURE AND SHAKE WELL BEFORE USING.

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  • GENERAL PRECAUTIONS

    RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED.

    DISPOSE OF CONTAINERS IN AN APPROVED LANDFILL OR BY INCINERATION.

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  • INGREDIENTS AND APPEARANCE
    PEN-AQUEOUS 
    penicillin g procaine injection, suspension
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:46066-151
    Route of Administration INTRAMUSCULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PENICILLIN G PROCAINE (PENICILLIN G) PENICILLIN G 300000 [USP'U]  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46066-151-01 250 mL in 1 VIAL, MULTI-DOSE
    2 NDC:46066-151-02 500 mL in 1 VIAL, MULTI-DOSE
    3 NDC:46066-151-03 100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA065505 09/22/2003
    Labeler - Aspen Veterinary Resources (627265361)
    Registrant - Bimeda Inc., Division of Cross Vetpharm Gropus (060492923)
    Establishment
    Name Address ID/FEI Business Operations
    Constant Irwindale Division of Cross Vetpharm Gropus 010569463 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Sandoz GmbH 300220969 api manufacture
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