ADVERSE REACTIONS SECTION.

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 PureVit DualFe Plus after meals may control occasional gastrointestinal disturbances. PureVit DualFe Plus is best absorbed when taken at bedtime. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:. PureVit DualFe Plus is unique in that it utilizes two different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganeite), making available total of 106 mg of elemental iron per capsule as follows:Ferrous Fumarate (anhydrous) 162 mg Polysaccharide Iron Complex (PIC) 115.2 mg Subclinical B-Group vitamin deficiencies have greatly increased in recent years due to changes in dietetic habits, increase in the use of sugar, and the excessive milling of flour and cereals. With thiamine deficiencies so prevalent in healthy populace, it is self-evident that the unwell person is particularly prone to thiamine avitaminosis. This is true of the anemic individual with his or her poor appetite and disturbed digestive functions. Folic acid is best known for its role in megaloblastic anemias. Zinc has been recognized in the nutrition of animals and humans, even though the evidence for an uncomplicated zinc deficiency in humans is limited. Ferrous Fumarate: Provides about 53 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As ferrous salt, it is more efficiently absorbed in the duodenum. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate.Polysaccharide Iron Complex: Provides about 53 mg of elemental iron, as cell-contracted akaganeite. It is product of ferric iron complexed to low molecular weight polysaccharide. This polysaccharide is produced by extensive hydrolysis of starch and is dark brown powder that dissolves in water to form very dark brown solution, which is virtually odorless and tasteless.Folic Acid: Folic Acid is one of the most important hematopoetic agents necessary for proper regeneration of the blood-forming elements and their function. Folic acid is precursor to large family of compounds which serve as coenzymes in carbon transfer reactions. These reactions are required for the synthesis of purine and pyrimidine bases, inter-conversion of glycine and serine, biosynthesis of methionine methyl groups and degradation of histidine. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. deficiency in folic acid results in megaloblastic anemia.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. PureVit DualFe Plus is contraindicated inpatients 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 acontraindication, as folic acid may obscure its signs and symptoms.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

GERIATRIC USE SECTION.

Geriatric Use:. No clinical studies have been performed in patients age 65 and over to determine whether older patients respond differently from younger patients. Dosage should always begin at the low end of the dosage scale and should consider that elderly patients may have decreased hepatic, renal or cardiac function, and of concomitant diseases.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. PureVit DualFe Plus are yellow capsules imprintedhorizontally P-112, bottles of 90 capsules NDC 59088-112-66. Dispensein tight, light-resistant container as defined in the USP/NF with achild resistant closure. Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature]. Keep in cool, dry place.

INDICATIONS & USAGE SECTION.

INDICATIONS:. PureVit DualFe Plus is indicated for the treatment of iron deficiencyanemia and folate deficiency as in extended convalescence, menorrhagia,pregnancy, puberty, excessive blood loss and advanced age. Also fortreatment of condition in which iron deficiency and vitamin Cdeficiency occur together, along with deficient intake or increasedneed for B-Complex vitamins in chronic and acute illness, as well ascases 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. PureVit DualFe Plus should be stored beyond the reach of children to prevent against 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Label. image of label.

PEDIATRIC USE SECTION.

Pediatric Use:. Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.

PRECAUTIONS:. General: Folic Acid in doses above 0.1 mg 0.4 mg daily may obscurepernicious anemia, in that hematological remission can occur whileneurological manifestations, remain progressive.. Pediatric Use:. Safety and effectiveness in pediatric patients have not been established.. Geriatric Use:. No clinical studies have been performed in patients age 65 and over to determine whether older patients respond differently from younger patients. Dosage should always begin at the low end of the dosage scale and should consider that elderly patients may have decreased hepatic, renal or cardiac function, and of concomitant diseases.. 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 PureVit DualFe Plus after meals may control occasional gastrointestinal disturbances. PureVit DualFe Plus is best absorbed when taken at bedtime. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

WARNINGS SECTION.

WARNING:. Accidental overdose of Iron-containing products is theleading cause of fatal poisoning of children under 6. Keep this productout of reach of children. In case of accidental overdose, call doctoror Poison Control Center immediately. Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin 12 is deficient.