Animal NDC 76475-347-50 Penicillin G Potassium

Animal Product Information

Field Name	Field Value
Animal NDC Code	76475-347-50
Proprietary Name	Penicillin G Potassium 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	Quo Vademus Llc
Product Type	Prescription Animal Drug
Usage Information	INDICATIONS: For the treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae).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: Combine contents and approximately 1 1/2 pints (710 mL) of water in a glass or plastic container. Stir to dissolve. Allow the concentrated solution to stand until the foam disappears. The concentrated solution should be used up or discarded within one hour after 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. In automatic watering systems, prepare fresh solutions daily.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 12 hours.Drinking water prepared as directed above will contain 1,500,000 units of penicillin G per gallon (3.8 liters). All solutions in contact with galvanized metal should be changed every three (3) hours.
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	ANADA200347 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.

Penicillin G Potassium Images

Penicillin G Potassium 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.

Description
General Precautions
Otc - Active Ingredient
Other
Indications & Usage
Warnings
Precautions
Principal Display Panel - 313 Gram Pouch

Description

NDC 76475-347-50

PENICILLIN G POTASSIUM USP

Antibiotic for drinking water

General Precautions

For oral use in turkeys only

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOR VETERINARY USE ONLY

Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.

KEEP OUT OF REACH OF CHILDREN

Restricted drug (under California law) - Use only as directed

Otc - Active Ingredient

Active Ingredient: 0.500 billion units penicillin G potassium

Nonsterile

Other

Approved by FDA under ANADA # 200-347

QUO VADEMUS

Manufactured by:

G. C. Hanford Manufacturing Co.

Syracuse, NY 13201 USA

Manufactured for:

Quo Vademus, LLC

Kenansville, NC 28349

Indications & Usage

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

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: Combine contents and approximately 1 1/2 pints (710 mL) of water in a glass or plastic container. Stir to dissolve. Allow the concentrated solution to stand until the foam disappears. The concentrated solution should be used up or discarded within one hour after 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. In automatic watering systems, prepare fresh solutions daily.

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 12 hours.

Drinking water prepared as directed above will contain 1,500,000 units of penicillin G per gallon (3.8 liters). All solutions in contact with galvanized metal should be changed every three (3) hours.

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.

Principal Display Panel - 313 Gram Pouch