Label: PANAKARE PLUS- pancreatic enzyme powder

  • NDC Code(s): 59051-9064-1, 59051-9064-2, 59051-9064-3
  • Packager: Neogen Corporation-Mercer
  • 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 January 23, 2024

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  • 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 of U.S and imported materials

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Neogen Corporation

    Lexington, KY 40511 859-254-1221

    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)

    Panakare Powder 4oz

  • 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)

    Panakare Powder 8oz

  • 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)

    Panakare Powder 12oz

  • INGREDIENTS AND APPEARANCE
    PANAKARE PLUS 
    pancreatic enzyme powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:59051-9064
    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:59051-9064-1113 g in 1 BOTTLE, PLASTIC
    2NDC:59051-9064-2227 g in 1 BOTTLE, PLASTIC
    3NDC:59051-9064-3340.2 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/06/2014
    Labeler - Neogen Corporation-Mercer (042125879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neogen Corporation-Mercer042125879analysis, manufacture, label
    Establishment
    NameAddressID/FEIBusiness Operations
    ALI Pharmaceutical Manufacturing, LLC080861914api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Scientific Protein Laboratories, LLC065240319api manufacture