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

PenAqua Sol-G by

Drug Labeling and Warnings

PenAqua Sol-G by is a Animal medication manufactured, distributed, or labeled by Bimeda Inc., Constant Irwindale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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 200-103 Approved by FDA

Net Contents: 0.500 billion I.U.

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 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).

INDICATIONS & USAGE

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PENAQUA SOL-G 
penicillin g potassium powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-5448
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PENICILLIN G POTASSIUM (UNII: VL775ZTH4C) (PENICILLIN G - UNII:Q42T66VG0C)	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
2	NDC: 61133-5448-1	1000000000 [iU] in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200103	09/12/2007

PENAQUA SOL-G 
penicillin g potassium powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-5449
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PENICILLIN G POTASSIUM (UNII: VL775ZTH4C) (PENICILLIN G - UNII:Q42T66VG0C)	PENICILLIN G	1000000000   in 1000000000 [iU]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-5449-1	1000000000 [iU] in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200103	08/02/2013	10/09/2015

Labeler - Bimeda Inc. (060492923)

Registrant - Bimeda Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Constant Irwindale		010569463	manufacture