Label: HEPATITIS-SODE (triticum aestivum, berberis vulgaris, chelidonium majus, taraxacum officinale, arsenicum album, glutathione, hepar suis, lymph (suis), phosphoricum acidum, spleen- suis, chelone glabra, germanium sesquioxide, hepatitis a nosode, hepatitis c nosode, hepatitis b nosode 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 April 21, 2015

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  • ACTIVE INGREDIENTS:

    Triticum Aestivum (Wheat) Mt, Berberis Vulgaris 3X, Chelidonium Majus 3X, Taraxacum Officinale 3X, Arsenicum Album 6X, Glutathione 6X, Hepar Suis 6X, Lymph (Suis) 6X, Phosphoricum Acidum 6X, Spleen (Suis) 6X, Chelone Glabra 6X, 12X, 30X, Germanium Sesquioxide 8X, Hepatitis A Nosode 18X, 60X, 100X, Hepatitis C Nosode 18X, 60X, 100X, Hepatitis B Nosode 33X, 60X, 100X.

  • INDICATIONS:

    May assist with temporary relief of symptoms related to exposure to Hepatitis A, B or C such as fatigue, muscle and joint aches, jaundice and loss of appetite.

  • WARNINGS:

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

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

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

  • 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:

    May assist with temporary relief of symptoms related to exposure to Hepatitis A, B or C such as fatigue, muscle and joint aches, jaundice and loss of appetite.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PACKAGE LABEL DISPLAY:

    Synergy Formulas

    HEPATITIS-SODE

    HOMEOPATHIC

    2 FL OZ (60 ml)

    HEPATITIS-SODE 2 OZ

  • INGREDIENTS AND APPEARANCE
    HEPATITIS-SODE 
    triticum aestivum, berberis vulgaris, chelidonium majus, taraxacum officinale, arsenicum album, glutathione, hepar suis, lymph (suis), phosphoricum acidum, spleen (suis), chelone glabra, germanium sesquioxide, hepatitis a nosode, hepatitis c nosode, hepatitis b nosode liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE1 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [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
    SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L) SUS SCROFA LYMPH6 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID6 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN6 [hp_X]  in 1 mL
    CHELONE GLABRA (UNII: 6G3UN932VF) (CHELONE GLABRA - UNII:6G3UN932VF) CHELONE GLABRA6 [hp_X]  in 1 mL
    GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE8 [hp_X]  in 1 mL
    HEPATITIS A VIRUS (UNII: G54MT8V18G) (HEPATITIS A VIRUS - UNII:G54MT8V18G) HEPATITIS A VIRUS18 [hp_X]  in 1 mL
    HEPATITIS C VIRUS (UNII: QI56415283) (HEPATITIS C VIRUS - UNII:QI56415283) HEPATITIS C VIRUS18 [hp_X]  in 1 mL
    HEPATITIS B VIRUS (UNII: 77H9EM77P7) (HEPATITIS B VIRUS - UNII:77H9EM77P7) HEPATITIS B VIRUS33 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0029-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/19/2015
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0029) , api manufacture(43772-0029) , label(43772-0029) , pack(43772-0029)
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