PANCREAPOWDER PLUS- pancreatic enzyme concentrate powder

PancreaPowder Plus by

Drug Labeling and Warnings

PancreaPowder Plus by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, Neogen Corporation-Mercer, American Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PANCREAPOWDER PLUS

Pancreatic Enzyme Concentrate

USE IN SPECIFIC POPULATIONS

For use in dogs and cats

Each 2.8 g (1 teaspoon) Contains a Minimum of:

Lipase..............................71,400 USP units

Protease.........................388,000 USP units

Amylase..........................460,000 USP units

Precautions:

Discontinue use in animals with symptoms of sensitivity or allergy. May cause temporary oral mucosal irritation that is treatable by reducing dose or diluting dose with a small amount of water. Consult with your veterinarian regarding dosing.

WARNINGS

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

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

Recommended Use:

As a digestive aid in replacement therapy where digestion of protein, carbohydrate and fat is inadequate due to exocrine pancreatic insufficiency.

Dosage:

Dose is administered before each meal and is estimated according to the severity of the condition and weight of the animal. PancreaPowder Plus is added to moistened food (canned or dry). Thorough mixing is necessary to bring the enzymes into close contact with the food particles. After mixing, let treated food stand at room temperature for 15-20 minutes prior to feeding.

Average Dose/Meal:

Dogs: 3/4-1 teaspoon (2.8 g/teaspoon), Cats: 1/4-3/4 teaspoon

STORAGE AND HANDLING

Store in tightly closed container in a dry place at a temperature between 15°-30°C (59°-86°F).

SPL UNCLASSIFIED SECTION

Distributed by:

Henry Schein Animal Health

Dublin, OH 43017

www.henryscheinvet.com

Questions? (859)724-3461

Made in USA

SPL UNCLASSIFIED SECTION

Manufactured by Neogen Corporation, Lexington, KY 40511

Lot No.:

Exp. Date

PRINCIPAL DISPLAY PANEL - 4 oz Bottle

Henry Schein®

Animal Health

NDC: 11695-1253-1

PancreaPowder Plus

Pancreatic Enzyme Concentrate

For use in dogs and cats

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

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

Net wt. 4 oz (113.4 g)

Reorder #062553

AH-062553-01

L1757-0418

Rev: 0418

PRINCIPAL DISPLAY PANEL - 12 oz Bottle

Henry Schein®

Animal Health

NDC: 11695-1253-3

PancreaPowder Plus

Pancreatic Enzyme Concentrate

For use in dogs and cats

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

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

Net wt. 12 oz (340 g)

Reorder #062555

AH-062555-01

L1507-0418

Rev: 0418

PRINCIPAL DISPLAY PANEL - 8 oz Bottle

Henry Schein®

Animal Health

NDC: 11695-1253-2

PancreaPowder Plus

Pancreatic Enzyme Concentrate

For use in dogs and cats

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

FOR ANIMAL USE ONLY

KEEP OUT OF THE REACH OF CHILDREN

Net wt. 8 oz (227 g)

Reorder #062554

AH-062554-01

L1756-0418

Rev: 0418

INGREDIENTS AND APPEARANCE

PANCREAPOWDER PLUS 
pancreatic enzyme concentrate powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-1253
Route of Administration	Oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O)	PANCRELIPASE LIPASE	71400 [iU]  in 2.8 g
PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)	PANCRELIPASE AMYLASE	460000 [iU]  in 2.8 g
PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50)	PANCRELIPASE PROTEASE	388000 [iU]  in 2.8 g

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-1253-1	113 g in 1 BOTTLE, PLASTIC
2	NDC: 11695-1253-2	227 g in 1 BOTTLE, PLASTIC
3	NDC: 11695-1253-3	340 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/06/2014

Labeler - Henry Schein Animal Health (603750329)

Establishment
Name	Address	ID/FEI	Business Operations
Neogen Corporation-Mercer		042125879	analysis, manufacture, label

Establishment
Name	Address	ID/FEI	Business Operations
American Laboratories, Inc.		042584839	api manufacture