Animal NDC 23243-6768-2 R-pen

Penicillin G Potassium

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-6768-2
Proprietary Name R-pen 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 Huvepharma, Inc.
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS:For treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae). INDICATIONS:For treatment of erysipelas in turkeys (causedby 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 ANADA200106 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.

R-pen 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



0.5 Bu Front Panel



Antibiotic

R-Pen®
(penicillin G potassium)

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

ANTIBIOTIC
for Drinking Water

Nonsterile

Active Ingredient:
0.500 billion units
penicillin G potassium

Mix 1 packet to 333 gallons water

Store between 20°C - 25°C
(68°F - 77°F) with excursions
permitted between 15°C - 40°C
(59°F - 104°F).

For Oral Use in Turkeys Only

Keep Out of Reach of Children

Made in Canada

Huvepharma®
Manufactured for:
Huvepharma, Inc.
525 Westpark Dr, Suite 230
Peachtree City, GA 30269

Restricted Drug (California) -
Use only as directed.
Not for human use

Approved by FDA under ANADA # 200-106

KCP-J00018 (Rev. 05-2023)

Huvepharma and R-Pen are registered trademarks of Huvepharma EOOD

104078A


Instructions For Use



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).

DIRECTIONS:
Combine contents of entire package and approximately 1.5 pints of water in glass or plastic container. Stir to dissolve. Allow the concentrated solution to stand until the foam disappears.

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 solution. [This amount of solution will medicate 333 gallons (1260 liters) of drinking water.] The automatic waterer should be adjusted to deliver 1 oz (30 ml) of stock solution per gallon (3.8 liters) of drinking water. In automatic watering systems, prepare fresh solutions every 12 hours.

Gravity Flow Watering Systems:

Pour the concentrated solution into enough water to make 666 gallons (2521 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).

DIRECTIONS:
Combine contents of entire package and approximately 3 pints of water in glass or plastic container. Stir to dissolve. Allow the concentrated solution to stand until the foam disappears.

Automatic Watering Systems:
Pour the concentrated solution into a glass or plastic container, then add enough water to make 5.2
gallons (19.7 liters) of solution. [This amount of solution will medicate 666 gallons (2521 liters) of drinking water.] The automatic waterer should be adjusted to deliver 1 oz (30 ml) of stock solution per gallon (3.8 liters) of drinking water. In automatic watering systems, prepare fresh solutions every 12 hours.


Residue Warning



RESIDUE 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.

RESIDUE 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. Keep this and all other medications out of the reach of children.

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. Keep this and all other medications out of the reach of children.


Veterinary Indications



INDICATIONS:

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

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.

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.


1.0 Bu Front Panel



Antibiotic

R-Pen®
(penicillin G potassium)

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

ANTIBIOTIC for Drinking Water

Nonsterile

Active Ingredient:
1.0 billion units
penicillin G potassium

Mix 1 packet to 666 gallons water

Store between 20°C - 25°C
(68°F - 77°F) with excursions
permitted between 15°C - 40°C
(59°F - 104°F).

For Oral Use in Turkeys Only

Keep Out of Reach of Children

Made in Canada

Huvepharma

Manufactured for:
Huvepharma, Inc.
525 Westpark Dr, Suite 230
Peachtree City, GA 30269

Restricted Drug (California) -

Use only as directed.
Not for human use

Approved by FDA under ANADA # 200-106

KCP-J00019 (Rev. 05-2023)

Huvepharma and R-Pen are registered trademarks of Huvepharma EOOD

104079A


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