PANCREPLUS- pancreatic enzyme tablet

PancrePlus by

Drug Labeling and Warnings

PancrePlus by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Neogen Corporation-Mercer, Scientific Protein Laboritories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PancrePlus™

Tablets

Pancreatic Enzyme Concentrate

For use in animals only.

Keep out of reach of children.

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

CONTAINS: Each tablet contains a minimum of:

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

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

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

DESCRIPTION:

PancrePlus™ is a pancreatic enzyme concentrate of porcine origin. It is indicated for use as a digestive aid in replacement therapy where digestion of protein, carbohydrate and fat is inadequate due to exocrine pancreatic insufficiency.

PRECAUTIONS:

Discontinue use in animals with symptoms of sensitivity or allergy.

SPL UNCLASSIFIED SECTION

MADE IN USA

DOSAGE & ADMINISTRATION:

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:

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

WARNINGS

TAKE TIME

OBSERVE LABEL DIRECTIONS

SPL UNCLASSIFIED SECTION

Distributed by: MWI

Boise, ID 83705

www.VetOne.net

Manufactured by:

Neogen Corporation

Lexington, KY 40511

Lot#:

Exp:

PRINCIPAL DISPLAY PANEL PancrePlus™ Tablets 100 Tablet Bottle

NDC: 13985-051-75

100 Tablets

VETone®

PancrePlus

Tablets

Pancreatic Enzyme Concentrate

For use in animals only.

Keep out of reach of children.

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

V1 501048 Net Contents: 100 Tablets

PRINCIPAL DISPLAY PANEL PancrePlus Tablets 500 Tablet Bottle

NDC: 13985-051-77

500 Tablets

VETone®

PancrePlus™

Tablets

Pancreatic Enzyme Concentrate

For use in animals only.

Keep out of reach of children.

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

V1 502048 Net Contents: 500 Tablets

INGREDIENTS AND APPEARANCE

PANCREPLUS 
pancreatic enzyme tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-051
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 PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50)	PANCRELIPASE PROTEASE	57000 [iU]
PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)	PANCRELIPASE AMYLASE	64000 [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: 13985-051-75	100 in 1 BOTTLE, PLASTIC
2	NDC: 13985-051-77	500 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/17/2013

Labeler - MWI/VetOne (019926120)

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