PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 13925-117-01 Se-Natal 19 Chewable Tablets A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation Rx Only 100 Tablets SETON PHARMACEUTICALS
INDICATIONS & USAGE SECTION.
INDICATIONS 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.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION One tablet daily, or as directed by a physician.
SPL UNCLASSIFIED SECTION.
PHARMACIST Dispense in a tight, light-resistant container as defined in the USP/INF with child-resistant closure. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx Only Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA 08/13 SETON PHARMACEUTICALS
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. NDC 13925-117-01
DESCRIPTION SeNatal 19 Chewable tablets are round, debossed "TL015." These tablets provide oil-soluble vitamins, water-soluble vitamins and minerals. Each tablet has the following active ingredient: Folate (folic acid) 1 mg Each tablet also contains the following ingredients for nutritional supplement: Vitamin A (as beta carotene) 1000 IU Vitamin C (calcium ascorbate) 100 mg Vitamin D3 (as cholecalciferol) 400 IU Vitamin E (as dl-alpha tocopheryl acetate) 30 IU Thiamine (Vitamin B1) (thiamine mononitrate) 3mg Riboflavin (Vitamin B2) 3 mg Niacinamide (Vitamin B3) 15 mg Vitamin B6 (as pyridoxine HCI) 20 mg Vitamin B12 (as cyanocobalamin) 12 mcg Pantothenic Acid (as D Calcium Pantothenate) 7 mg Calcium (as calcium carbonate) 200 mg Iron (as ferrous fumarate) 29 mg Zinc (as zinc oxide) 20 mg
PRECAUTIONS Folic acid in doses above 0.8 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
STORAGE AND HANDLING SECTION.
STORAGE Store at 20-25C (68-77F [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.
INACTIVE INGREDIENT SECTION.
INACTIVE INGREDIENTS Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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 a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.