Se-Tan PLUS

SE-TAN PLUS- ferrous fumarate, iron dextran, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, niacinamide, calcium pantothenate, zinc sulfate , manganese sulfate and cupric sulfate capsule, gelatin coated
Seton Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Ferrous Fumarate / Polysaccharide Iron Complex / Multivitamin Mineral Capsules

Rx Only

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 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.

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 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.

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.

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

WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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.

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.

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.

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.

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.

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

PRINCIPAL DISPLAY PANEL

NDC 13925-118 -90

Se-Tan-PLUS

Ferrous Fumarate / Polysaccharide Iron Complex / Multivitamin Mineral Capsules

90 Capsules

Rx Only

SETON PHARMACEUTICALS

Container Label
(click image for full-size original)
SE-TAN PLUS
multivitamin/mineral capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 162 mg
IRON DEXTRAN (FERRIC CATION) FERRIC CATION 115.2 mg
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 200 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 10 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 6 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 5 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 30 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg
ZINC SULFATE (ZINC CATION) ZINC CATION 18.2 mg
MANGANESE SULFATE (MANGANESE CATION (2+)) MANGANESE CATION (2+) 1.3 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 0.8 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code T503
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13925-118-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2009
Labeler — Seton Pharmaceuticals (828898002)

Revised: 02/2024 Seton Pharmaceuticals

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