Label: FNGSODE- ceanothus americanus, condurango, echinacea, hydrastis canadensis, ligusticum porteri, lomatium dissectum, nasturtium aquaticum 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 August 12, 2013

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  • ACTIVE INGREDIENTS:

    Ceanothus Americanus 1X, Condurango 3X, Echinacea 3X, Hydrastis Canadensis 3X, Ligusticum Porteri 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, 6X, Astragalus Membranaceus 6X, Propolis 6X, Borax 6X, 12X, Spleen (Bovine) 8X, Thymus (Bovine) 8X, Glandula Suprarenalis Bovine 8X, 12X, 60X, Kidney (Suis) 8X, 12X, 60X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Candida Albicans 12X, 30X, 60X, 100X.

  • INDICATIONS:

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

  • 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,​ as a health professional before use.

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

  • DIRECTIONS:

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

  • 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:

    For temporary relief of allergice rhinitis, bloating, heartburn, and intolerance of dried fruits.

  • QUESTIONS:

    Distributed by:

    SYNERGY FORMULAS, INC.

    251 West Road

    Campobello, SC 29322

  • PACKAGE DISPLAY LABEL:

    Synergy Formulas

    FNGSODE

    HOMEOPATHIC

    2 FL OZ (60 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    FNGSODE 
    ceanothus americanus, condurango, echinacea, hydrastis canadensis, ligusticum porteri, lomatium dissectum, nasturtium aquaticum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0016
    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, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
    LIGUSTICUM PORTERI ROOT (UNII: 81FGO4H42J) (LIGUSTICUM PORTERI ROOT - UNII:81FGO4H42J) LIGUSTICUM PORTERI ROOT3 [hp_X]  in 1 mL
    LOMATIUM DISSECTUM ROOT (UNII: 5329928G5N) (LOMATIUM DISSECTUM ROOT - UNII:5329928G5N) LOMATIUM DISSECTUM ROOT3 [hp_X]  in 1 mL
    NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM AQUATICUM - UNII:YH89GMV676) NASTURTIUM OFFICINALE3 [hp_X]  in 1 mL
    TABEBUIA IMPETIGINOSA BARK (UNII: 6GLA1946WX) (TABEBUIA IMPETIGINOSA BARK - UNII:6GLA1946WX) TABEBUIA IMPETIGINOSA BARK3 [hp_X]  in 1 mL
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF) ASTRAGALUS PROPINQUUS ROOT6 [hp_X]  in 1 mL
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX6 [hp_X]  in 1 mL
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE6 [hp_X]  in 1 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN8 [hp_X]  in 1 mL
    BOS TAURUS THYMUS (UNII: 8XEJ88V2T8) (BOS TAURUS THYMUS - UNII:8XEJ88V2T8) BOS TAURUS THYMUS8 [hp_X]  in 1 mL
    BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND8 [hp_X]  in 1 mL
    PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H) PORK KIDNEY8 [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 ALBICANS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43772-0016-160 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/12/2013
    Labeler - Synergy Formulas, Inc. (069579220)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43772-0016) , api manufacture(43772-0016) , label(43772-0016) , pack(43772-0016)
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