Animal NDC 61133-5448-3 Penaqua Sol-g
Penicillin G Potassium

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-5448-3
Proprietary Name Penaqua Sol-g What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Penicillin G Potassium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Bimeda Inc.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS: For treatment of erysipelas in turkeys caused by Erysipelothrix rhusiopathiae.
Active Ingredient(s)
  • Penicillin G Potassium
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200103 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Penaqua Sol-g Images

Penaqua Sol-g Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


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* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.