ALPHA.-TOCOPHEROL, DL-: 215 Adverse Event Reports & Safety Profile

DESCRIPTION: Full Prescribing Information: Each Serving Size of 2 caplets contain: Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE Vitamin C (as Ascorbic Acid)............................................................... 500 mg Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg Riboflavin ............................................................................................. 6.7 mg Niacin (as Niacinamide)......................................................................... 45 mg Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg Biotin ................................................................................................ 200 mcg Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg Calcium (as Calcium Carbonate)...........................................................150 mg Iron (as Ferrous Fumarate)......................................................................18 mg Iodine (as Potassium Iodide)................................................................50 mcg Magnesium (as Magnesium Oxide)........................................................ 75 mg Zinc (as Zinc Gluconate)......................................................................... 30 mg Selenium (as Selenomethionine)...........................................................60 mcg Copper (as Copper Oxide)....................................................................... 2 mg Manganese (as Manganese Sulfate).......................................................1.5 mg Chromium (as Chromium Polynicotinate)..............................................75 mcg Molybdenum (as Sodium Molybdate)................................................... 50 mcg Potassium (as Potassium Chloride)....................................................... 49 mg Boron (as Boron Citrate)...................................................................... 50 mcg Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).

INDICATIONS AND USAGE Supplementation of the diet with fluoride and ten essential vitamins. Multivitamin with 1.0 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm. Multivitamin with 0.5 mg Fluoride Chewable Tablet s provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with 0.25 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride Chewable Tablets supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Supplementation of the diet with fluoride for caries prophylaxis.

The American

Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Children using Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable tablets are prescription product for the clinical dietary management of metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age) Two (2) Ribotin-E TM caplets daily, between meals or as directed by a physician. Do not administer to children under the age of 12 unless directed by a physician.

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

The American

Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide 0.52 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Flotrex™ Multivitamin Chewable plus 0.25 mg Fluoride Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

Adverse Reactions: Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. Iron: 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 Davimet™ with Iron Multivitamin Chewable Tablets after meals may controloccasional gastrointestinal disturbances. Davimet™ with Iron Multivitamin Chewable Tablets 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, allergicand idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in somepatients

WARNING: Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. 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 accidentaloverdose, call a doctor or poison control center immediately. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. CAUTION: Should be chewed. 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 alleviatingthe hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before thecorrect 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. Use only under the direction of a licensed 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: Davimet™ with Iron Multivitamin Chewable Tablets are not recommended and should not be given to patients receiving levodopa because the action oflevodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin orClopidogrel).

Adverse

Reactions: Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. Iron: 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 Davimet™ with Iron Multivitamin Chewable Tablets after meals may controloccasional gastrointestinal disturbances. Davimet™ with Iron Multivitamin Chewable Tablets 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, allergicand idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in somepatients

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 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 B 12 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: Ventrixyl™ 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 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 usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Drug Interactions: Prenatrix 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 Prenatrix after meals may control occasional gastrointestinal disturbances. Prenatrix 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.

OTHER INGREDIENTS Bovine Gelatin, Glycerin, Soybean Oil, Soy Lecithin, Purified Water, Yellow Beeswax, FD&C Red # 40, Titanium Dioxide, Orange Cream Flavor, Ethyl Vanillin, FD&C Yellow # 6, and FD&C Blue #1. Contains soy.