FDA Label for Se-tan Plus
View Indications, Usage & Precautions
Se-tan Plus Product Label
The following document was submitted to the FDA by the labeler of this product Seton Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Inactive Ingredients:
FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Gelatine, Magnesium Stearate, Microcrystalline Cellulose, Silica, Titanium Dioxide.
Indications:
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.
Warnings
WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
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.
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. NDC 13925-118-90.
Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Storage:
Store at controlled room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep in a cool, dry place.
Principal Display Panel
NDC 13925-118-90
Se-Tan-PLUS
Ferrous Fumarate / Polysaccharide Iron Complex /
Multivitamin Mineral Capsules
90 Capsules
Rx Only
SETON PHARMACEUTICALS
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