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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.

DESCRIPTION. Se-Natal 19 is white, oblong, film coated tablet, debossed TL 019. Each film coated tablet contains:Supplement FactsServings per Bottle: 100Serving Size: tabletEach Tablet contains:% DV for Pregnant and Lactating WomenVitamin (as beta carotene)1000 IU23%Vitamin (ascorbic acid)100 mg83%Vitamin (as cholecalciferol)10 mcg67%Vitamin (as dl-alpha tocoperol 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 Acid (as calcium pantothenate) mg 100% Calcium (as calcium carbonate)200 mg15%Iron (as ferrous fumarate)29 mg107%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 tablets for oral administration are supplied as white, coated, oblong tablets debossed TL019, packaged in bottles of 100 tablets.Product Code: 13925-116-01.

INACTIVE INGREDIENT SECTION.

OTHER INGREDIENTS. Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.

INDICATIONS & USAGE SECTION.

INDICATIONS. Se-Natal 19 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 tablets are also useful in improving the nutritional status of women prior to conception.

OVERDOSAGE SECTION.

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 13925-116-01Se-Natal 19 TabletsVitamins and Minerals with Folic Acid100 TabletsRx OnlySETON PHARMACEUTICALS. PRINCIPAL DISPLAY PANEL 100 tablets.

PRECAUTIONS SECTION.

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.

Vitamins Minerals with Folic AcidRx 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 SECTION.

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.