Label: HEPATAPLEX- boldo, carduus marianus, chelidonium majus, lappa major, petroselinum sativum, taraxacum officinale, glutathione, hepar suis, lycopodium clavatum, nux vomica, phosphorus liquid

  • 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 September 7, 2022

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  • ACTIVE INGREDIENTS:

    Boldo 3X, Carduus Marianus 3X, Chelidonium Majus 3X, Lappa Major 3X, Petroselinum Sativum 3X, Taraxacum Officinale 3X, Glutathione 6X, Hepar Suis 6X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphorus 12X.

  • INDICATIONS:

    For temporary relief of abdominal bloating, & soreness, constipation alternating with diarrhea.

  • WARNINGS:

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

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

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

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of abdominal bloating, & soreness, constipation alternating with diarrhea.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    HEPATAPLEX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Hepataplex

  • INGREDIENTS AND APPEARANCE
    HEPATAPLEX 
    boldo, carduus marianus, chelidonium majus, lappa major, petroselinum sativum, taraxacum officinale, glutathione, hepar suis, lycopodium clavatum, nux vomica, phosphorus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0627
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF3 [hp_X]  in 1 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE3 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 mL
    PETROSELINUM CRISPUM WHOLE (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM WHOLE3 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE6 [hp_X]  in 1 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER6 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0627-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/07/2022
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0627) , api manufacture(43857-0627) , label(43857-0627) , pack(43857-0627)
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