Ferrous Fumarate, Polysaccharide Iron Complex
FDA Drug Information • Also known as: Purevit Dualfe Plus
- Brand Names
- Purevit Dualfe Plus
- Drug Class
- Vitamin B12 [EPC]
- Route
- ORAL
- Dosage Form
- CAPSULE
- Product Type
- HUMAN PRESCRIPTION DRUG
What Is Ferrous Fumarate, Polysaccharide Iron Complex Used For?
INDICATIONS: PureVit DualFe Plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.
Side Effects (Adverse Reactions)
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 and Precautions
WARNING: Accidental overdose of Iron-containing products is the leading cause of fatal poisoning of children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately. Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
Contraindications
CONTRAINDICATIONS: PureVit DualFe Plus is contraindicated in patients 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 a contraindication, as folic acid may obscure its signs and symptoms.
Overdosage
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.
How Supplied
HOW SUPPLIED: PureVit DualFe Plus are yellow capsules imprinted horizontally "P-112", bottles of 90 capsules NDC 59088-112-66. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep in a cool, dry place.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.