Vitrexate Tablet
FDA Label NDC 59088-167

Each caplet contains:

Vitamin A (as retinyl acetate)………………………….. 1500 mcg

Vitamin C (as ascorbic acid)……………………………… 120 mg

Vitamin D3 (as cholecalciferol)…………………………… 20 mcg

Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg

Thiamine (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).

Vitrexate 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.

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

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

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 B12 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.

Vitrexate is not recommended for and should not be given to patients receiving

levodopa because the action of levodopa is antagonized by pyridoxine. There is a

possibility of increased bleeding due to pyridoxine interaction with anticoagulants

(e.g., Aspirin, Heparin or Clopidogrel).

Allergic sensitization has been reported following both oral and parenteral

administration of folic acid.

Adverse reactions have been reported with specific vitamins and minerals but

generally at levels substantially higher than those contained herein. However,

allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the

usual recommended levels, has been associated with gastrointestinal intolerance in

some patients.

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

Vitrexate are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-167-54. Dispense in a tight,
a light-resistant container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20°-25°C (68°-77°F). [See USP]. Protect from
light and moisture and avoid excessive heat.

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°-25°C (68°-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.

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873