HOW SUPPLIED SECTION.

HOW SUPPLIED:. Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets NDC 59088-167-54NDC 59088-171-54Dispense in tight, light-resistant container as defined in the USP/NF with child-resistant closure.Store at controlled room temperature 20o-25oC (68o-77oF). [See USP]. Protect from light and moisture and avoid excessive heat.

INDICATIONS & USAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

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

ADVERSE REACTIONS SECTION.

Adverse Reactions:. 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. Contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.

DESCRIPTION:. Each caplet contains:Vitamin (as retinyl acetate)................................ 1500 mcg Vitamin (as ascorbic acid).................................... 120 mg Vitamin D3 (as cholecalciferol)................................. 20 mcg Vitamin (dl-alpha tocopheryl acetate)........................ 30 mg Thiamine (as thiamine mononitrate).............................. 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)................................ 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).

DOSAGE & ADMINISTRATION SECTION.

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

DRUG INTERACTIONS SECTION.

Drug Interactions:. Not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).

PRECAUTIONS SECTION.

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 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 patients medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. For use on the order of 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. Drug Interactions:. Not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel).. Adverse Reactions:. 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

STORAGE AND HANDLING SECTION.

Storage. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20o-25oC (68o-77oF). [See USP]. Protect from light and moisture and avoid excessive heat. To report serious adverse event or to obtain product information, contact 1-877-921-7873.

WARNINGS SECTION.

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