Ferrous Fumarate / Polysaccharide Iron Complex Supplement Capsules

Other Ingredients: Microcrystalline Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FDA/E172 Yellow Iron Oxide, FDA/172 Black Iron Oxide, FDA/E172 Red Iron Oxide
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NDC 52747-0900-90  90Capsules  OTC


Ferrous Fumarate / Polysaccharide Iron Complex Supplement Capsules

WARNING: 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 accidental overdose, call a doctor or poison control center immediately.

You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036.

INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron, or an excessive loss of iron.

CONTRAINDICATIONS: All iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis and hemolytic anemias.

PRECAUTIONS: Existing gastrointestinal diseases, i.e. peptic ulcers, regional enteritis, ulcerative colitis may be aggravated by causing the iron not to be absorbed and therefore, be ineffective in patients with steatorrhea or those with a partial gastrectomy. It is important to determine and treat the underlying cause of the anemia, in addition to the administration of Tandem®. Indefinite administration of iron should be avoided.

SIDE EFFECTS: Gastrointestinal disturbance (anorexia, ausea, diarrhea, constipation) occur occasionally but are usually mild and subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Tandem® after meals may control occasional G.I. disturbances. Tandem® is best absorbed when taken at bedtime.

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. Tandem® should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this product and all 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.

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

WARNING: Do not administer to pediatric patients. Do not exceed recommended dosage. Keep this product and all drugs out of reach of children. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Observe iron warnings on blister package.

HOW SUPPLIED: Tandem® are light brown opaque capsules imprinted radially "Tandem" "US, US, US, US/US, US, US, US": Child resistant 9 units of 10 capsules, each blister packs in containers of 90 capsules (NDC 52747-900-90). Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at room temperature between 15°-30°C (59°-86°F). Keep in cool dry place.

Rev. 04/2011