Ventrixyl: Package Insert / Prescribing Info

Ventrixyl Description

Each caplet contains:

Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)
Vitamin C (as ascorbic acid)……………….……………… 120 mg
Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU)
Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU)
Thiamin (as thiamine mononitrate)…………...……………… 3 mg
Riboflavin (vitamin B2)…………………………...…………. 3.4 mg
Niacin (as niacinamide)…………………………....………… 20 mg
Vitamin B6 (as pyridoxine hydrochloride)………….………. 20 mg
Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)
Vitamin B12 (as cyanocobalamin)………………….……….. 8 mcg
Calcium (as calcium carbonate)……………………...……. 200 mg
Magnesium (as magnesium oxide)……………………...… 200 mg
Zinc (as zinc oxide)………………………………………..... 25 mg
Selenium (as selenium amino acid chelate)……………….55 mcg
Manganese (as manganese sulfate)………………………. 2.3 mg
Chromium (as chromium polynicotinate)………………..... 35 mcg
Molybdenum (as molybdenum amino acid chelate)……... 45 mcg

Other Ingredients:
Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).

Indications and Usage for Ventrixyl

Ventrixyl™ is indicated to provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch

Ventrixyl Dosage and Administration

One (1) Ventrixy™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

How is Ventrixyl supplied

Ventrixyl™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-186-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Storage and Handling

Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
Protect from light and moisture and avoid excessive heat.
To report a serious adverse event or to obtain product information, contact
877-921-7873.

Chronocap

Ventrixyl™

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

List No: 18654IAA Rev: 38311