Label: FNGSODE- ceanothus americanus, condurango, echinacea angustifolia, hydrastis canadensis, ligusticum porteri, lomatium, nasturtium aquaticum, tabebuia impetiginosa, astragalus membranaceus, 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 28, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Ceanothus americanus 1X, Condurango 3X, Echinacea angustifolia 3X, Hydrastis canadensis 3X, Ligusticum porteri 3X, Lomatium 3X, Nasturtium aquaticum 3X, Tabebuia impetiginosa 3X, 6X, Astragalus membranaceus 6X, Propolis 6X, Borax 6X, 12X, Spleen 8X, Thymus 8X, Glandula suprarenalis 8X, 12X, 60X, Kidney 8X, 12X, 60X, Phosphoricum acidum 12X, Phytolacca decandra 12X, Sepia 12X, Candida albicans 12X, 30X, 60X, 100X.


  • PURPOSE

    INDICATIONS:  For temporary relief of allergic rhinitis, bloating, heartburn, and intolerance of dried fruits.

  • WARNINGS

    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.


  • DOSAGE & ADMINISTRATION

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

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.


  • 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.


  • INDICATIONS & USAGE

    INDICATIONS:  For temporary relief of allergic rhinitis, bloating, heartburn, and intolerance of dried fruits.

  • QUESTIONS

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PRINCIPAL DISPLAY PANEL

    SYNERGY  FORMULAS

    FNGSODE

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Fngsode

  • INGREDIENTS AND APPEARANCE
    FNGSODE 
    ceanothus americanus, condurango, echinacea angustifolia, hydrastis canadensis, ligusticum porteri, lomatium, nasturtium aquaticum, tabebuia impetiginosa, astragalus membranaceus, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0571
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N) CEANOTHUS AMERICANUS LEAF1 [hp_X]  in 1 mL
    MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA) MARSDENIA CONDURANGO BARK3 [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
    LOMATIUM DISSECTUM ROOT (UNII: 5329928G5N) (LOMATIUM DISSECTUM ROOT - UNII:5329928G5N) LOMATIUM DISSECTUM ROOT3 [hp_X]  in 1 mL
    RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676) (RORIPPA NASTURTIUM-AQUATICUM - UNII:YH89GMV676) RORIPPA NASTURTIUM-AQUATICUM3 [hp_X]  in 1 mL
    TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (TABEBUIA IMPETIGINOSA BARK - UNII:6GLA1946WX) TABEBUIA IMPETIGINOSA BARK6 [hp_X]  in 1 mL
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF) ASTRAGALUS PROPINQUUS ROOT6 [hp_X]  in 1 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BORATE12 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN8 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS8 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND60 [hp_X]  in 1 mL
    PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H) PORK KIDNEY60 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS100 [hp_X]  in 1 mL
    LIGUSTICUM PORTERI ROOT (UNII: 81FGO4H42J) (LIGUSTICUM PORTERI ROOT - UNII:81FGO4H42J) LIGUSTICUM PORTERI ROOT3 [hp_X]  in 1 mL
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0571-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/21/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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