PANCREPLUS- pancreatic enzyme powder

PancrePlus by

Drug Labeling and Warnings

PancrePlus by is a Animal medication manufactured, distributed, or labeled by MWI/VetOne, Neogen Corporation-Mercer, ALI Pharmaceutical Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CONTAINS:

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

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

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

Amylase..........................460,000 USP unitsC

DESCRIPTION:

PancrePlus™ is a pancreatic enzyme concentrate of porcine origin.

INDICATIONS & USAGE

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. May cause oral mucosal irritation.

DOSAGE & ADMINISTRATION:

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:

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

PRINCIPAL DISPLAY PANEL - 4 oz Bottle

NDC 13985-081-41         4 oz

VETone®

PancrePlus™

Powder

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 503048      Net Contents:4 oz (113 g)

PRINCIPAL DISPLAY PANEL - 8 oz Bottle

NDC 13985-081-42       8 oz

VETone®

PancrePlus™

Powder

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 504048       Net Contents: 8 oz (227 g)

PRINCIPAL DISPLAY PANEL - 12 oz Bottle

NDC 13985-081-53       12 oz

VETone®

PancrePlus™

Powder

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 505048       Net Contents: 12 oz (340 g)

INGREDIENTS AND APPEARANCE

PANCREPLUS 
pancreatic enzyme powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 13985-081
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: 13985-081-41	113 g in 1 BOTTLE, PLASTIC
2	NDC: 13985-081-42	227 g in 1 BOTTLE, PLASTIC
3	NDC: 13985-081-53	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 - MWI/VetOne (019926120)

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