Label: PENAQUA SOL-G- penicillin g potassium powder, for solution

  • NDC Code(s): 61133-5448-3
  • Packager: Bimeda Inc., Division of Cross Vetpharm Group
  • 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 09/13

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  • SPL UNCLASSIFIED SECTION

    PenAqua Sol-G®

    (penicillin G potassium, USP)

    FOR ORAL USE IN TURKEYS ONLY

    ANTIBIOTIC for drinking water

    Nonsterile

    ACTIVE INGREDIENT:

    0.500 billion units penicillin G potassium

    NOT FOR USE IN HUMANS

    KEEP OUT OF REACH OF CHILDREN´╗┐

    Restricted Drug (California) - Use Only as Directed

    ANADA 200-301 Approved by FDA

    Net Contents: 0.500 billion I.U.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:Administer orally at a dosage of 1,500,000 units of penicillin per gallon (3.8 liters) of drinking water for 5 consecutive days.

    DIRECTIONS: Dissolve contents of pouch in 2 pints (946 mL) of water in glass or plastic container. Shake well to dissolve. Allow the concentrated solution to stand until the foam disappears. The concentrated solution should be used up or discarded within one hour of preparation.

    Automatic Watering Systems: Pour the concentrated solution into a glass or plastic container, then add enough water to make 2.6 gallons (9.9 liters) of stock solution. [This amount of solution will medicate 333 gallons (1260 liters) of drinking water]. The automatic waterer should be adjusted to deliver 1 ounce (30 mL) of stock solution per gallon (3.8 liters) of drinking water. Prepare fresh stock solutions and medicated drinking water solutions every twelve (12) hours. All solutions in contact with galvanized metal should be changed every three (3) hours.

    Gravity Flow Watering Systems: Pour the concentrated solution into enough water to make 333 gallons (1260 liters) of drinking water. In gravity flow watering systems, prepare fresh solution every 12 hours. All solutions in contact with galvanized metal should be changed every three (3) hours.

    Drinking water prepared as directed above will contain 1,500,000 units of Penicillin G Potassium per gallon (3.8 liters).

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  • INDICATIONS & USAGE

    INDICATIONS: For treatment of erysipelas in turkeys caused by Erysipelothrix rhusiopathiae.

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  • WARNINGS

    WARNINGS: Treated turkeys must not be slaughtered for food during treatment and for one day after last treatment.

    Do not use in turkeys producing eggs for human consumption.

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  • PRECAUTIONS

    PRECAUTIONS: For best results, the treatment should be started at the first sign of infection. If improvement is not noted after 3 to 4 days of treatment, consult a poultry pathologist or veterinarian. Use only as directed. Store at or below 25°C (77°F). Protect from excessive heat, 40°C (104°F), and moisture. Label recommendations for storage and replacement of stock and medicated water solutions must be followed to assure the performance of this drug product.

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  • INGREDIENTS AND APPEARANCE
    PENAQUA SOL-G 
    penicillin g potassium powder, for solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61133-5448
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PENICILLIN G POTASSIUM (PENICILLIN G) PENICILLIN G 500000000 [iU]  in 500000000 [iU]
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61133-5448-3 500000000 [iU] in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200103 09/12/2007
    Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
    Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923)
    Establishment
    Name Address ID/FEI Business Operations
    Constant Irwindale, Division of Cross Vetpharm Group 010569463 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    CSPC Zhongnuo Pharmaceutical (Shijiazhuang)Co.,Ltd. 654663376 api manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Fersinsa Gb, S.A. de C.V. 814622007 api manufacture
    Establishment
    Name Address ID/FEI Business Operations
    CSPC Zhongrun Pharmaceutical (Inner Mongolia) Co., Ltd. 545265563 api manufacture
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