ADVERSE REACTIONS SECTION.

Adverse Reactions:. Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. 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 Finazol(TM) after meals may control occasional gastrointestinal disturbances. Finazol(TM) 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.

DESCRIPTION SECTION.

DESCRIPTION:. Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin (as Retinyl Acetate) .........................................1500 mcg RAE Vitamin (as Ascorbic Acid) ....................................................200 mg Vitamin D3 (as Cholecalciferol) ......................................10 mcg (400 IU) Vitamin (as DL-alpha Tocopheryl Acetate) ...................................45 mg Thiamin (as Thiamine Mononitrate) ...........................................3.25 mg Riboflavin (as Vitamin B2) ......................................................3.35 mg Niacin (as Niacinamide)........................................................22.5 mg Vitamin B6 (as Pyridoxine HCl)...................................................6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) .....................1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)............................................26 mcg Biotin............................................................................100 mcg Pantothenic Acid (as Calcium Pantothenate)...................................15 mg Calcium (as Calcium Carbonate)...............................................100 mg Iron (as Ferrous Fumarate).......................................................18 mg Iodine (as Potassium Iodide)...................................................25 mcg Magnesium (as Magnesium Oxide).............................................50 mg Zinc (as Zinc Citrate)..............................................................30 mg Selenium (as Selenomethionine)...............................................30 mcg Copper (as Copper Oxide)..........................................................1 mg Manganese (as Manganese Sulfate)..........................................0.75 mg Chromium (as Chromium Polynicotinate)..................................37.5 mcg Molybdenum (as Sodium Molybdate).........................................25 mcg Potassium (as Potassium Chloride) ..........................................24.5 mg Boron (as Boron Citrate)........................................................25 mcg Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow 6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide.

INDICATIONS & USAGE SECTION.

INDICATIONS:. Finazol(TM) is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions 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. Finazol(TM) should be stored beyond the reach of children to prevent against accidental iron poisoning. Treatment:. For specific therapy, exchange transfusion and chelating agents should be used. For general management, gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

PRECAUTIONS SECTION.

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 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 patients medical conditions and consumption of other drugs, herbs, and or supplements should be considered.For use on the order of 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.

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.. 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 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 patients medical conditions and consumption of other drugs, herbs, and or supplements should be considered.For use on the order of 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:. Finazol(TM) 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:. Folate: Allergic sensitizations have been reported following both oral and parenteral administration of folate. 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 Finazol(TM) after meals may control occasional gastrointestinal disturbances. Finazol(TM) 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.