Vitrexate FE Package Insert

DESCRIPTION:

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

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).

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 a condition in which iron deficiency and

vitamin C deficiency occur together, along with a deficient intake or increased need for

B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in

convalescence.

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 a

contraindication, as folic acid may obscure its signs and symptoms.

WARNING:

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children

under 6. Keep this product out of reach of children. In case of accidental overdose, call a 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 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.

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 a 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.

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.

DOSAGE AND ADMINISTRATION:

Adults (persons over 12 years of age) One (1) VitrexylTM + Iron

caplet daily, between meals or as directed by a physician. Do not administer to children under

the age of 12.

HOW SUPPLIED:

Vitrexate FE are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-168-54. 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:

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.