Multitam drug information

DOSAGE AND ADMINISTRATION: Take one (1) Multitam™ caplet daily, preferably between meals, or as directed by a licensed healthcare practitioner.

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

WARNINGS: Folate alone is not appropriate therapy for pernicious anemia and other megaloblastic anemias associated with vitamin B12 deficiency.

Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folate. 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.

Drug Interactions: Multitam™ 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).

DESCRIPTION: Active Ingredients: Each Caplet Contains: Vitamin A (as Retinyl Acetate).....................................1500 mcg RAE Vitamin C (as Ascorbic Acid)...................................................120 mg Vitamin D3 (as Cholecalciferol).................................20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (Vitamin E)...................................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-Methylfolate) Vitamin B12 (as Methylcobalamin)...........................................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, coating (hydroxypropyl methylcellulose, polyethylene glycol 400, organic maltodextrin, organic sunflower lecithin, organic sunflower oil, organic guar gum).

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. To be used only under the supervision of a licensed healthcare practitioner. Call your licensed healthcare practitioner 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: Multitam™ 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: Allergic sensitization has been reported following both oral and parenteral administration of folate. 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.

HOW SUPPLIED: Multitam™ caplets are beige, speckled, oblong, coated caplets supplied in bottles of 30 (NDC 59088-525-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Storage Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled RoomTemperature]. Protect from light and moisture. Avoid excessive heat. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. To report a serious adverse event or to obtain product information, contact PureTek Corporation at 1-877-921-7873.