Label: LYMESODE (chelidonium majus, echinacea- angustifolia, hydrastis canadensis, nasturtium aquaticum, taraxacum officinale, trifolium pratense, rhus toxicodendron, arnica montana, 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 June 23, 2014

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  • ACTIVE INGREDIENTS:

    Chelidonium majus 3X, Echinacea (Angustifolia) 3X, Hydrastis canadensis 3X, Nasturtium aquaticum 3X, Taraxacum officinale 3X, Rhus toxicodendron 5X, 12X, Arnica montana 6X, Glandula suprarenalis suis 6X, Medulla ossis suis 6X, Thymus (Suis) 6X, Oxalicum acidum 6X, 12X, Magnesia phosphorica 8X, Latrodectus mactans 8X, 12X, Borrelia burgdorferi nosode 12X, 30X, 200X, Encephalitis nosode 12X, 30X, 200X, Meningococcus nosode 15X, 30X, 200X, Hepatitis B nosode 30X, 200X.

  • INDICATIONS:

    For temporary relief of aches, pains and fatigue associated with Lyme disease.

  • 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:


    For temporary relief of aches, pains and fatigue associated with Lyme disease.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PACKAGE LABEL DISPLAY:

    Synergy Formulas

    LYMESODE

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Lymesode

  • INGREDIENTS AND APPEARANCE
    LYMESODE 
    chelidonium majus, echinacea (angustifolia), hydrastis canadensis, nasturtium aquaticum, taraxacum officinale, trifolium pratense, rhus toxicodendron, arnica montana, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
    NASTURTIUM AQUATICUM (UNII: YH89GMV676) (NASTURTIUM AQUATICUM - UNII:YH89GMV676) NASTURTIUM AQUATICUM3 [hp_X]  in 1 mL
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF5 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND6 [hp_X]  in 1 mL
    SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW6 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS6 [hp_X]  in 1 mL
    OXALIC ACID (UNII: 9E7R5L6H31) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID6 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 1 mL
    LATRODECTUS MACTANS (UNII: XJJ7QA858R) (LATRODECTUS MACTANS - UNII:XJJ7QA858R) LATRODECTUS MACTANS8 [hp_X]  in 1 mL
    BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8) BORRELIA BURGDORFERI12 [hp_X]  in 1 mL
    JAPANESE ENCEPHALITIS VIRUS (UNII: P07E7XWU9D) (JAPANESE ENCEPHALITIS VIRUS - UNII:P07E7XWU9D) JAPANESE ENCEPHALITIS VIRUS12 [hp_X]  in 1 mL
    NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (NEISSERIA MENINGITIDIS - UNII:V3TP2MD7F3) NEISSERIA MENINGITIDIS15 [hp_X]  in 1 mL
    HEPATITIS B VIRUS (UNII: 77H9EM77P7) (HEPATITIS B VIRUS - UNII:77H9EM77P7) HEPATITIS B VIRUS30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0021-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/23/2014
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0021) , api manufacture(43772-0021) , label(43772-0021) , pack(43772-0021)
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