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

  • NDC Code(s): 61133-5448-1, 61133-5448-3, 61133-5449-1
  • Packager: Bimeda Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated January 30, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DESCRIPTION

    PenAqua Sol-G®
    (penicillin G potassium, USP)
    FOR ORAL USE IN TURKEYS ONLY
    ANTIBIOTIC for drinking water
    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
    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
    Approved by FDA under ANADA # 200-103
    Net Contents: 0.500 billion I.U.

  • INDICATIONS & USAGE

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

  • 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 solutions every twelve (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).

  • 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.

  • 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.

    The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

  • PRINCIPAL DISPLAY PANEL

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    PENAQUA SOL-G 
    penicillin g potassium powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-5448
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENICILLIN G POTASSIUM (UNII: VL775ZTH4C) (PENICILLIN G - UNII:Q42T66VG0C) PENICILLIN G500000000 [iU]  in 500000000 [iU]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-5448-3500000000 [iU] in 1 POUCH
    2NDC:61133-5448-11000000000 [iU] in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20010309/12/2007
    PENAQUA SOL-G 
    penicillin g potassium powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-5449
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENICILLIN G POTASSIUM (UNII: VL775ZTH4C) (PENICILLIN G - UNII:Q42T66VG0C) PENICILLIN G1000000000   in 1000000000 [iU]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-5449-11000000000 [iU] in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20010308/02/201310/09/2015
    Labeler - Bimeda Inc. (060492923)
    Registrant - Bimeda Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Constant Irwindale010569463manufacture