Label: STOMACH ENZYME FORMULA (betainum muriaticum, muriaticum acidum, natrum phosphoricum, pancreas suis, stomach- suis symphytum officinale, pepsinum spray

  • NDC Code(s): 83027-0106-1
  • 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 4, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Betainum Muriaticum 6X, Muriaticum Acidum 6X, Natrum Phosphoricum 6X, Pancreas Suis 6X, Stomach 6X, Symphytum Officinale 6X, Pepsinum 12X.

  • PURPOSE:

    Aids in stimulating and balancing stomach enzyme release.†

    †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 stimulating and balancing stomach enzyme release.†

    †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 DISPLAY:

    Professional

    Health Products

    HOMEOPATHIC

    NDC 83027-0106-1

    STOMACH

    ENZYME

    FORMULA

    2 FL. OZ (60 ml)

    STOMACH  ENZYME  FORMULA

  • INGREDIENTS AND APPEARANCE
    STOMACH ENZYME FORMULA 
    betainum muriaticum, muriaticum acidum, natrum phosphoricum, pancreas suis, stomach (suis) symphytum officinale, pepsinum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETAINE HYDROCHLORIDE (UNII: JK8U8K4D6K) (BETAINE - UNII:3SCV180C9W) BETAINE HYDROCHLORIDE6 [hp_X]  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID6 [hp_X]  in 1 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE6 [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 STOMACH (UNII: T0920P9Z9A) (SUS SCROFA STOMACH - UNII:T0920P9Z9A) SUS SCROFA STOMACH6 [hp_X]  in 1 mL
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
    PEPSIN (UNII: GID333S43J) (PEPSIN - UNII:GID333S43J) PEPSIN12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0106-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/04/2023
    Labeler - Nutritional Specialties, Inc. (032744609)