PANAKARE PLUS- pancreatic enzyme tablet

PanaKare Plus by

Drug Labeling and Warnings

PanaKare Plus by is a Animal medication manufactured, distributed, or labeled by Neogen Corporation-Mercer, ALI Pharmaceutical Manufacturing, LLC, Scientific Protein Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​PanaKare™Plus Tablets

​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 tablet contains a minimum of:

Lipase..............................9,000 USP units

Protease.........................57,000 USP units

Amylase..........................64,000 USP units

​Description:

PanaKare Plus is a pancreatic enzyme concentrate of porcine origin.

​Precautions:

Discontinue use in animals with symptoms of sensitivity or allergy.

SPL UNCLASSIFIED SECTION

Made in the USA

WARNINGS

​KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

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.

​Average dose/meal:

Dogs: 2-3 tablets

Cats: 1/2-1 tablet

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

Lot No.:

Exp. Date:

Manufactured by: Neogen Corporation

Lexington, KY 40511 859-254-1221

animalsafety.neogen.com

​PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle

NDC: 59051-9067-7

​PanaKare™Plus Tablets

​Pancreatic Enzyme Concentrate

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

Net Contents: 500 Tablets

L1731-0318

​PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle

​NDC: 59051-9067-5

​PanaKare™Plus Tablets

​Pancreatic Enzyme Concentrate

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

Net Contents: 100 Tablets

L1730-0318

INGREDIENTS AND APPEARANCE

PANAKARE PLUS 
pancreatic enzyme tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 59051-9067
Route of Administration	Oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O)	PANCRELIPASE LIPASE	9000 [iU]
PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)	PANCRELIPASE AMYLASE	64000 [iU]
PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50)	PANCRELIPASE PROTEASE	57000 [iU]

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59051-9067-7	500 in 1 BOTTLE, PLASTIC
2	NDC: 59051-9067-5	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/15/2013

Labeler - Neogen Corporation-Mercer (042125879)

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

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