Vitramyn drug information

Dosage and Administration: The recommended dosage is one (1) Vitramyn™ tablet daily, taken between meals or as directed by a physician. Vitramyn™ tablets are not recommended for use in children under 12 years of age.

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

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

Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folate derivatives. Adverse reactions have been reported with individual vitamins and minerals, generally at levels substantially higher than those contained in this product. However, allergic and idiosyncratic reactions may occur even at lower levels. Gastrointestinal intolerance (e.g., nausea, abdominal discomfort) has been reported with certain vitamins and minerals, particularly at higher doses. 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: Vitramyn™ 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 antiplatelet agents (e.g., aspirin, clopidogrel) and anticoagulants (e.g., heparin).

DESCRIPTION: Each tablet contains: Vitamin A (as retinyl acetate)……………….. 1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….……………… 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) Vitamin E (as dl-Alpha-Tocopheryl Acetate)……….....……. 30 mg Thiamin (as thiamine mononitrate)…………...……………… 3 mg Riboflavin.....................…………………………...…………. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) 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: Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, organic cocoa powder, silicon dioxide, stearic acid, clear coating: hydroxypropyl methylcellulose, polyethylene glycol 400, organic guar gum, organic maltodextrin, organic sunflower lecithin, organic sunflower oil.

PRECAUTIONS: Folate 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 folate to patients with undiagnosed anemia, since folate 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. Drug Interactions: Vitramyn™ 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 antiplatelet agents (e.g., aspirin, clopidogrel) and anticoagulants (e.g., heparin). Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folate derivatives. Adverse reactions have been reported with individual vitamins and minerals, generally at levels substantially higher than those contained in this product. However, allergic and idiosyncratic reactions may occur even at lower levels. Gastrointestinal intolerance (e.g., nausea, abdominal discomfort) has been reported with certain vitamins and minerals, particularly at higher doses. 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.

HOW SUPPLIED: Vitramyn™ is supplied as beige, speckled, oblong, film-coated, caplet-shaped tablets in bottles of 30 (NDC 59088-193-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Avoid excessive heat.

Do not use if the seal under the bottle cap is broken. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.