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 October 15, 2019

If you are a consumer or patient please visit this version.

  • 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

  • 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.

  • 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.

  • 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.

  • WARNINGS

    None

  • ADVERSE REACTIONS

    Post-marketing Experience

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

  • OVERDOSAGE

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

  • CLINICAL PHARMACOLOGY

    Mechanism of Action

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

    Pharmacodynamics

    Not applicable for homeopathic medicinal products.

  • DOSAGE & ADMINISTRATION

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

  • PRINCIPAL DISPLAY PANEL

    WellMind Vertigo RX Tablet.jpg

  • INGREDIENTS AND APPEARANCE
    WELLMIND VERTIGO 
    semecarpus anacardium juice, anamirta cocculus seed, conium maculatum flowering top, kerosene, and selenium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50114-9001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE6 [hp_X]
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED4 [hp_X]
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP3 [hp_X]
    PETROLEUM ALKYLATE (UNII: Y61895R84U) (PETROLEUM ALKYLATE - UNII:Y61895R84U) PETROLEUM ALKYLATE8 [hp_X]
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Mountain
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-9001-21 in 1 CARTON01/01/2015
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2015
    Labeler - MediNatura Inc. (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc.102783016manufacture(50114-9001)