Se-Tan PLUS drug information

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.

CONTRAINDICATIONS : Se-Tan PLUS is contraindicated in patients with a 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.

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.

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

Ferrous Fumarate / Polysaccharide Iron Complex / Multivitamin Mineral Capsules R x Only WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Rx Only RESERVED FOR PROFESSIONAL RECOMMENDATION. Manufactured for: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA Code 118-90 Rev.03/18 SETON PHARMACEUTICALS

DESCRIPTION: Se-Tan PLUS are white capsules imprinted in black "T503". Each capsule contains: Supplement Facts Servings per Bottle: 90 Serving Size: 1 capsule Each Capsule contains: ​%DV for ​Adults Iron (as ferrous fumarate anhydrous) 32.5 mg 181% Polysaccharide Iron Complex 115.2 mg 642% Vitamin C (Sodium Ascorbate) 200 mg 222% Vitamin B 1 (Thiamine Mononitrate) 10 mg 833% Vitamin B 2 (Riboflavin) 6 mg 462% Vitamin B ​6 ​ (Pyridoxine HCl) 5 mg 294% Vitamin B ​12 ​ (Cyanocobalamin Concentrate) 15 mcg 250% Folate (folic acid) 1000 mcg 250% Niacinamide 30 mg 188% Pantothenic Acid (as Calcium Panothenate) 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 89% Table text from source: Supplement Facts | Servings per Bottle: 90Serving Size: 1 capsuleEach Capsule contains: | ​%DV for​Adults | Iron (as ferrous fumarate anhydrous) | 32.5 mg | 181% | Polysaccharide Iron Complex | 115.2 mg | 642% | Vitamin C (Sodium Ascorbate) | 200 mg | 222% | Vitamin B1 (Thiamine Mononitrate) | 10 mg | 833% | Vitamin B2 (Riboflavin) | 6 mg | 462% | Vitamin B​6​ (Pyridoxine HCl) | 5 mg | 294% | Vitamin B​12​ (Cyanocobalamin Concentrate) | 15 mcg | 250% | Folate (folic acid) | 1000 mcg | 250% | Niacinamide | 30 mg | 188% | Pantothenic Acid (as Calcium Panothenate) | 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 | 89%

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

​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 a 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 eryhtropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a 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 megaloblasticmacrocytic anemias. Vitamin B ​12 ​ is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and mylein synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.

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.

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. 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.

HOW SUPPLIED: Se-Tan PLUS are white capsules imprinted in black "T503". Child resistant bottles of 90 capsules. Product Code: NDC 13925-118-90. ​ ​PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

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