Label: WELLMIND VERTIGO- semecarpus anacardium juice, anamirta cocculus seed, conium maculatum flowering top, kerosene, and selenium tablet

  • Category: HUMAN PRESCRIPTION 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 May 7, 2015

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  • DESCRIPTION

    Each 300 mg tablet contains:

    Active Ingredients:

    Ingredient name               Potency        Quantity    Final dilution

    Anacardium orientale        6X                 10 mg        7.5X

    Cocculus indicus               4X                 210 mg      4.15X

    Conium maculatum           3X                 30 mg       4X

    Petroleum                        8X                 20 mg       9.2X

    Selenium metallicum        6X                 10 mg       7.5X

    Selenium metallicum        12X               10 mg      13.5X

    Selenium metallicum       30X                10 mg      31.5X

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  • INDICATIONS & USAGE

    WellMindTM Vertigo Tablets are a homeopathic drug product indicated for the treatment of vertigo/dizziness ofvarious origins; mild cognitive impairment (MCI) such as lack of concentration and forgetfulness.

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  • DOSAGE AND ADMINISTRATION

    General Considerations

    • The dosage schedules listed below can be used as a general guide for the administration of WellMindTM Vertigo Tablets.

    • Allow tablets to dissolve completely in the mouth, do not swallow.

    Standard Dosage: Adults and children 12 years and older:

    3 tablets per day, taking 1 tablet every 4 to 6 hours.

    Acute Dosage:Adults and children 12 years and older:

    1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.

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  • CONTRAINDICATIONS

    • WellMindTM Vertigo Tablets are contraindicated in patients with known hypersensitivity to WellMindTM Vertigo or any of its ingredients.

    Do not use during pregnancy or breastfeeding.

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  • WARNINGS

    None

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  • ADVERSE REACTIONS

    Post-marketing Experience

    • No adverse events with a causal relationship to WellMindTM Vertigo tablets have been reported.

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  • OVERDOSAGE

    No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

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  • CLINICAL PHARMACOLOGY

    Mechanism of Action

    The exact mechanism of WellMindTM Vertigo Tablets is not fully understood.

    Pharmacodynamics

    Not applicable for homeopathic medicinal products.

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  • DOSAGE & ADMINISTRATION

    300 mg tablets each containing the active ingredients in the strengths listed under Description.

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  • WellMind Vertigo
  • INGREDIENTS AND APPEARANCE
    WELLMIND VERTIGO 
    semecarpus anacardium juice, anamirta cocculus seed, conium maculatum flowering top, kerosene, and selenium tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50114-9001
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 6 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 4 [hp_X]
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 3 [hp_X]
    PETROLEUM ALKYLATE (UNII: Y61895R84U) (PETROLEUM ALKYLATE - UNII:Y61895R84U) PETROLEUM ALKYLATE 8 [hp_X]
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code Mountain
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50114-9001-2 1 in 1 CARTON
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/01/2015
    Labeler - MediNatura Inc. (102783016)
    Establishment
    Name Address ID/FEI Business Operations
    MediNatura Inc. 102783016 manufacture(50114-9001)
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