Label: APO-ENTERIT- citrullus colocynthis fruit pulp, podophyllum, veratrum album root, artemisia abrotanum flowering top, cynara scolymus whole, and potentilla anserina flowering top solution/ drops

  • NDC Code(s): 59469-158-10
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 December 2, 2022

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

  • ACTIVE INGREDIENT

    Ingredients:
    Citrullus colocynthis (Colocynthis)4X
    Podophyllum peltatum4X
    Veratrum album4X
    Artemisia abrotanum15.20 mg/ml
    Cynara scolymus42.74 mg/ml
    Potentilla anserina21.84 mg/ml

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 41% alcohol by volume.

  • Indications

    For occasional diarrhea and minor stomach cramps. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA®
    GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

    apo-ENTERIT
    Oral Drops

    Homeopathic Medicine

    For occasional
    diarrhea and minor
    stomach cramps

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    APO-ENTERIT 
    citrullus colocynthis fruit pulp, podophyllum, veratrum album root, artemisia abrotanum flowering top, cynara scolymus whole, and potentilla anserina flowering top solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-158
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Citrullus colocynthis Fruit Pulp (UNII: 23H32AOH17) (Citrullus colocynthis Fruit Pulp - UNII:23H32AOH17) Citrullus colocynthis Fruit Pulp4 [hp_X]  in 50 mL
    Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum4 [hp_X]  in 50 mL
    Veratrum album Root (UNII: QNS6W5US1Z) (Veratrum Album Root - UNII:QNS6W5US1Z) Veratrum album Root4 [hp_X]  in 50 mL
    Artemisia abrotanum Flowering Top (UNII: QG07G580U0) (Artemisia abrotanum Flowering Top - UNII:QG07G580U0) Artemisia abrotanum Flowering Top760 mg  in 50 mL
    Cynara scolymus Whole (UNII: 9N3437ZUU0) (Cynara Scolymus Whole - UNII:9N3437ZUU0) Cynara scolymus Whole2137 mg  in 50 mL
    Potentilla anserina Flowering Top (UNII: H00Y243SK0) (Potentilla anserina Flowering Top - UNII:H00Y243SK0) Potentilla anserina Flowering Top1092 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-158-101 in 1 BOX04/12/2008
    150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/12/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-158)