PANAKARE PLUS- pancreatic enzyme powder

PanaKare Plus by

Drug Labeling and Warnings

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

Drug Details [pdf]

PanaKare™ Plus Powder

​Pancreatic Enzyme Concentrate

​

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

USE IN SPECIFIC POPULATIONS

​FOR ANIMAL USE ONLY

COMPONENTS

Each 2.8 grams (1 teaspoon) contains a minimum of:

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

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

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

Description

PanaKare Plus is a pancreatic enzyme concentrate of porcine origin.

​Precautions:

Discontinue use in animals with symptoms of sensitivity. May cause oral mucosal irritation.

SPL UNCLASSIFIED SECTION

Made in the USA

SPL UNCLASSIFIED SECTION

Lot No.:

Exp. Date:

Manufactured by: Neogen Corporation

Lexington, KY 40511  859-254-1221

animalsafety.neogen.com

WARNINGS

​KEEP OUT OF REACH OF CHILDREN

​Indications:

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

Directions for use:

Dose is administered before each meal. Estimate dose according to the severity of the condition and weight of the animal. PanaKare 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 stand at room temperature for 15-20 minutes.

Average dose/meal:

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

Cats: 1/4-3/4 teaspoon

STORAGE AND HANDLING

​Store tightly closed container in a dry place at temperatures not exceeding 35°C (95°F).

PRINCIPAL DISPLAY PANEL - 4 oz Bottle

NDC: 59051-9064-1

PanaKare™ Plus Powder

Pancreatic Enzyme Concentrate

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

Net Contents: 4 oz Powder (113 g)

L1728-0318

PRINCIPAL DISPLAY PANEL - 8 oz Bottle

NDC: 59051-9064-2

PanaKare™ Plus Powder
Pancreatic Enzyme Concentrate

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

Net Contents: 8 oz Powder (227 g)

L1729-0418

PRINCIPAL DISPLAY PANEL - 12 oz Bottle

NDC: 59051-9064-3

PanaKare™ Plus Powder

Pancreatic Enzyme Concentrate

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

Net Contents: 12 oz Powder (340.2 g)

L1480-0318

INGREDIENTS AND APPEARANCE

PANAKARE PLUS 
pancreatic enzyme powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 59051-9064
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: 59051-9064-1	113 g in 1 BOTTLE, PLASTIC
2	NDC: 59051-9064-2	227 g in 1 BOTTLE, PLASTIC
3	NDC: 59051-9064-3	340.2 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 - Neogen Corporation-Mercer (042125879)

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