ADVERSE REACTIONS SECTION.

Adverse Reactions:. Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Vitrexyl Iron after meals may control occasional gastrointestinal disturbances. Vitrexyl Iron is best absorbed when taken at bedtime. 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is contraindication, as folic acid may obscure its signs and symptoms.

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 Iron (as ferrous fumarate)....................................... 27 mg Magnesium (as magnesium oxide)........................... 200 mg Zinc (as zinc oxide)............................................... 25 mg Selenium (as selinium 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:. Adults (persons over 12 years of age) One (1) VitrexylTM Iron caplet daily, between meals or as directed by physician. Do not administer to children under the age of 12.

DRUG INTERACTIONS SECTION.

Drug Interactions:. Vitrexate FE is 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).

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Vitrexate FE are beige speckled, oblong, coated caplets, bottles containing 30 caplets NDC 59088-168-54. Dispense in tight, light-resistant container as defined in the USP/NF with child-resistant closure. Store at controlled room temperature 20 to 25C (68 to 77F). [See USP]. Protect from light and moisture and avoid excessive heat.

INDICATIONS & USAGE SECTION.

INDICATIONS:. Vitrexate FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age.Also for the treatment of condition in which iron deficiency and vitamin deficiency occur together, along with deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

OVERDOSAGE SECTION.

OVERDOSE:. Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Vitrexate FE should be stored beyond the reach of children to prevent accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment:. For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

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

PRECAUTIONS SECTION.

Precaustion Section. 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.

SPL UNCLASSIFIED SECTION.

Treatment:. For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

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 20 to 25C (68 to 77F). [See USP]. Protect from light and moisture and avoid excessive heat. To report serious adverse event or to obtain product information, contact 877-921-7873.

WARNINGS SECTION.

WARNING:. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. Precaustion Section. 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:. Vitrexate FE is 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:. Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Vitrexyl Iron after meals may control occasional gastrointestinal disturbances. Vitrexyl Iron is best absorbed when taken at bedtime. 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.