ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
BOXED WARNING SECTION.
WARNING: Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately.
CLINICAL PHARMACOLOGY SECTION.
CLINICAL PHARMACOLOGY. Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemogloblin syntheis 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 megablastic 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. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION. Se.Natal 19 Chewable tablets are round, debossed TL015. These tablets provide oil-soluble vitamins, water-soluble vitamins and minerals. Each tablet contains:Supplement FactsServings per Bottle:100%DV For Pregnant and Lactating WomenServing Size1 chewable tabletEach Tablet contains:Vitamin (as beta carotene)1000 IU23%Vitamin (calcium ascorbate)100 mg83%Vitamin (as cholecalciferol)10 mcg67%Vitamin (as dl-alpha tocopherol acetate)30 IU142%Thiamine (Vitamin B1)3 mg214%Riboflavin (Vitamin B2)3 mg188%Niacin (as niacinamide)15 mg83%Vitamin B6 (as pyridoxine HCl)20 mg1000%Folate (folic acid)1000 mcg167%Vitamin B12 (as cyanocobalamin)12 mcg 429% Pantothenic Aicd (as calcium pantothenate) mg 100%Calcium (as calcium carbonate)200 mg15%Iron (as ferrous fumarate)29 mg 107% Zinc (as zinc oxide) 20 mg 154%.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One tablet daily, or as directed by physician.
DRUG INTERACTIONS SECTION.
DRUG INTERACTIONS. Prescriber should be aware of number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
HOW SUPPLIED SECTION.
HOW SUPPLIED. Se-Natal 19 Chewable Tablets for oral administration are supplied as multi-color-speckled, round tablets debossed TL015, packaged in bottles of 100 tablets.Product Code: 13925-117-01.
INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS. Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.
INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE. Se-Natal 19 Chewable Tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 Chewable Tablets are also useful in improving the nutritional status of women prior to conception.
OVERDOSAGE. Symptoms:. Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. NDC 13925-117-01Se-Natal 19 Chewable TabletsA Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional SupplementationRx Only100 TabletsSETON PHARMACEUTICALS. PRINCIPAL DISPLAY PANEL 100 tablets.
PRECAUTIONS. GENERAL. Take hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.. Folic Acid. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia. In that hematologic remission can occur while neurological manifestations remain progressive.. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. Geriatric Use. Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.
SPL UNCLASSIFIED SECTION.
A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional SupplementationRx Only.
STORAGE AND HANDLING SECTION.
STORAGE. Store at 20-25C (68-77F), excursions permitted to 15-30C (59-86F)[See USP controlled room temperature].
WARNINGS. 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 leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately.