Vertigoheel

Heel Inc

Vertigoheel Rx Tablet

FULL PRESCRIBING INFORMATION: CONTENTS*

• VERTIGOHEEL DESCRIPTION
• INDICATION AND USAGE
• VERTIGOHEEL DOSAGE AND ADMINISTRATION
• VERTIGOHEEL CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• VERTIGOHEEL ADVERSE REACTIONS
• OVERDOSAGE
• CLINICAL PHARMACOLOGY
• DOSAGE

FULL PRESCRIBING INFORMATION

VERTIGOHEEL DESCRIPTION

Each 300mg tablet contains:

Inactive Ingredients

Lactose Diluent for homeopathic dilutions

Magnesium stearate  1%

INDICATION AND USAGE

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

VERTIGOHEEL DOSAGE AND ADMINISTRATION

General Considerations

• The dosage schedules listed below can be used as a general guide for the administration of Vertigoheel® 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.

VERTIGOHEEL CONTRAINDICATIONS

• Vertigoheel® Tablets are contraindicated in patients with known hypersensitivity to Vertigoheel® or any of its ingredients.
• Do not use during pregnancy or breastfeeding.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

VERTIGOHEEL ADVERSE REACTIONS

Post-marketing Experience

• The following adverse events have been identified during post-marketing use of Vertigoheel® Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Allergic (hypersensitivity) skin reactions may occur in isolated cases.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203

info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 Vertigoheel® Tablets is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

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