Label: DIGESTIVE ENZYME FORMULA (gallbladder (bovine), hepar (bovine), intestine (suis), pancreas suis, rectal mucosa (suis), stomach- suis spray

  • NDC Code(s): 83027-0111-1
  • Packager: Nutritional Specialties, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 5, 2023

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  • ACTIVE INGREDIENTS:

    Gallbladder 6X, 12X, 30X, Hepar 6X, 12X, 30X, Intestine 6X, 12X, 30X, Pancreas Suis 6X, 12X, 30X, Rectal Mucosa 6X, 12X, 30X, Stomach 6X, 12X, 30X.

  • PURPOSE:

    Aids in temporary relief of minor digestive disorders and provides enzymatic help.†

    †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    Professional Use Only

    If pregnant or breast-feeding, ask a health professional before use.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    If condition worsens, seek medical attention.

    KEEP OUT OF REACH OF CHILDREN

    Do not use if tamper evident seal is broken or missing.

    Store in a cool place after opening

  • KEEP OUT OF REACH OF CHILDREN:

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Aids in temporary relief of minor digestive disorders and provides enzymatic help.†

    †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Alcohol USP 20%, Purified Water USP.

  • QUESTIONS:

    MANUFACTURED EXCLUSIVELY FOR

    NUTRITIONAL SPECIALTIES, INC.

    PO BOX 97227

    PITTSBURG, PA 15229

    www.phpltd.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Professional

    Health Products

    HOMEOPATHIC

    NDC 83027-0111-1

    DIGESTIVE

    ENZYME

    FORMULA

    2 FL. OZ (60 ml)

    DIGESTIVE ENZYME FORMULA

  • INGREDIENTS AND APPEARANCE
    DIGESTIVE ENZYME FORMULA 
    gallbladder (bovine), hepar (bovine), intestine (suis), pancreas suis, rectal mucosa (suis), stomach (suis) spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BOS TAURUS GALLBLADDER (UNII: 9901V1E867) (BOS TAURUS GALLBLADDER - UNII:9901V1E867) BOS TAURUS GALLBLADDER6 [hp_X]  in 1 mL
    HEPARIN, BOVINE (UNII: P776JQ4R2F) (HEPARIN, BOVINE - UNII:P776JQ4R2F) HEPARIN, BOVINE6 [hp_X]  in 1 mL
    PORK INTESTINE (UNII: 40GMI0R60L) (PORK INTESTINE - UNII:40GMI0R60L) PORK INTESTINE6 [hp_X]  in 1 mL
    SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS6 [hp_X]  in 1 mL
    SUS SCROFA RECTAL MUCOSA (UNII: 03T60V100Y) (SUS SCROFA RECTAL MUCOSA - UNII:03T60V100Y) SUS SCROFA RECTAL MUCOSA6 [hp_X]  in 1 mL
    SUS SCROFA STOMACH (UNII: T0920P9Z9A) (SUS SCROFA STOMACH - UNII:T0920P9Z9A) SUS SCROFA STOMACH6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0111-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/05/2023
    Labeler - Nutritional Specialties, Inc. (032744609)
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