Label: PANCREPLUS- pancreatic enzyme powder

  • NDC Code(s): 13985-081-41, 13985-081-42, 13985-081-53
  • Packager: MWI/VetOne
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 19, 2020

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  • 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)

    PancrePlus Powder 4oz

  • 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)

    PancrePlus Powder 8oz

  • 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)

    PancrePlus Powder 12oz

  • INGREDIENTS AND APPEARANCE
    PANCREPLUS 
    pancreatic enzyme powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-081
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE71400 [iU]  in 2.8 g
    PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E) PANCRELIPASE AMYLASE460000 [iU]  in 2.8 g
    PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50) PANCRELIPASE PROTEASE388000 [iU]  in 2.8 g
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-081-41113 g in 1 BOTTLE, PLASTIC
    2NDC:13985-081-42227 g in 1 BOTTLE, PLASTIC
    3NDC:13985-081-53340.2 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/06/2014
    Labeler - MWI/VetOne (019926120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neogen Corporation-Mercer042125879analysis, manufacture, label