Label: FNG II (echinacea (angustifolia), lomatium dissectum, nasturtium aquaticum, tabebuia impetiginosa, hydrastis canadensis, iodium, adrenalinum, argentum metallicum, thymus (suis), thyroidinum (suis), phosphoricum acidum, candida albicans, lycopodium clavatum, pulsatilla- vulgaris, sepia liquid

  • NDC Code(s): 43857-0424-1
  • Packager: BioActive Nutritional, Inc.
  • 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 December 20, 2016

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  • ACTIVE INGREDIENTS:

    Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Hydrastis Canadensis 5X, Iodium 6X, Adrenalinum 8X, Argentum Metallicum 8X, Thymus (Suis) 8X, Thyroidinum (Suis) 8X, Phosphoricum Acidum 12X, Candida Albicans 12X, 30X, Lycopodium Clavatum 30X, Pulsatilla (Vulgaris) 30X, Sepia 30X.

  • INDICATIONS:

    For temporary relief of bloating of the stomach, flatulence, and allergic rhinitis.

  • 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 bloating of the stomach, flatulence, and allergic rhinitis.

  • 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

    FNG II

    1 FL OZ (30 ml)

    FNG II

  • INGREDIENTS AND APPEARANCE
    FNG  II
    echinacea (angustifolia), lomatium dissectum, nasturtium aquaticum, tabebuia impetiginosa, hydrastis canadensis, iodium, adrenalinum, argentum metallicum, thymus (suis), thyroidinum (suis), phosphoricum acidum, candida albicans, lycopodium clavatum, pulsatilla (vulgaris), sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0424
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [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 OFFICINALE - 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
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE6 [hp_X]  in 1 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE8 [hp_X]  in 1 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER8 [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 THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID8 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0424-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2016
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0424) , api manufacture(43857-0424) , label(43857-0424) , pack(43857-0424)
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