PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 13925-118-90Se-Tan-PLUSFerrous Fumarate Polysaccharide Iron Complex Multivitamin Mineral Capsules90 CapsulesRx OnlySETON PHARMACEUTICALS. Container Label.

PEDIATRIC USE SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS:. General:. Folic acid in doses above 0.1 mg 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.. Pediatric Use:. Safety and effectiveness of this product have not been established in pediatric patients.. Geriatric Use:. No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases.

SPL UNCLASSIFIED SECTION.

Ferrous Fumarate Polysaccharide Iron Complex Multivitamin Mineral Capsules Rx Only.

STORAGE AND HANDLING SECTION.

Storage:. Store at 20 25C(68 77F), excursions permitted to 15 30C (59 86F) [See USP controlled room temperature]. Keep in cool, dry place.

WARNINGS SECTION.

WARNING:. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

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 Se-Tan PLUS after meals may control occasional G.I. disturbances. Se-Tan PLUS is best absorbed when taken at bedtime.

BOXED WARNING SECTION.

WARNING: Accidental overdose of iron- containing products is the leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDRN. In case of accidental overdose, call doctor poison control center immediately.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B12 is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. Se-Tan PLUS is contraindicated in patients with known hyper sensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is contraindication, as folic acid may obscure its signs and symptoms.

DESCRIPTION SECTION.

DESCRIPTION:. Se-Tan PLUS are white capsules imprinted in blackT503. Each capsule contains:Supplement FactsServings per Bottle: 90Serving Size: capsuleEach Capsule contains:% DV for Adults Iron (as ferrous fumarate anhydrous) 162 mg 889% Polysaccharide Iron Complex 115.2 mg 642% Vitamin (Sodium Ascorbate) 200 mg 222% Vitamin B1 (Thiamine Mononitrate) 10 mg 833% Vitamin B2 (Riboflavin) mg 462% Vitamin B6 (Pyridoxine HCI) mg 294% Vitamin B12 (Cyanocobalamin Concentrate) 15 mcg 250% Folate (folic acid) 1000 mcg 250% Niacinamide 30 mg 188% Pantothenic Acid (as Calcium Pantothenate) 10 mg 200% Zinc (as Zinc Sulfate) 18.2 mg 165% Manganese (as Manganese Sulfate) 1.3 mg 57% Copper (as Copper Sulfate) 0.8 mg 57%.

DOSAGE & ADMINISTRATION SECTION.

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

DRUG INTERACTIONS SECTION.

DRUG INTERACTIONS:. Prescriber should be aware of number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

GENERAL PRECAUTIONS SECTION.

General:. Folic acid in doses above 0.1 mg 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

GERIATRIC USE SECTION.

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

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Se-Tan PLUS are white capsules imprinted in black T503. Child resistant bottles of 90 capsules. Product Code: 13925-118-90.

INACTIVE INGREDIENT SECTION.

OTHER INGREDIENTS:. FD&C Blue 1, FD&C Red 40, FD&C Yellow 6, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Silica, Titanium Dioxide.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE:. Se-Tan 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 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 over-dosage 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. Se-Tan PLUS should be stored beyond the reach of children to prevent against accidental iron poisoning.Keep this and all other drugs out of the 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.