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  5. Label Information: Wellmind Vertigo

FDA Label for Wellmind Vertigo

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS & USAGE
    3. DOSAGE AND ADMINISTRATION
    4. CONTRAINDICATIONS
    5. WARNINGS
    6. ADVERSE REACTIONS
    7. OVERDOSAGE
    8. CLINICAL PHARMACOLOGY
    9. DOSAGE & ADMINISTRATION
    10. WELLMIND VERTIGO

Wellmind Vertigo Product Label

The following document was submitted to the FDA by the labeler of this product Medinatura Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


* Please review the disclaimer below.