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Se-Natal 19 Chewable (Seton Pharmaceuticals)

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TABLET, CHEWABLE 100 TABLET, CHEWABLE in 1 BOTTLE (13925-117-01) Label Information

Complete Se-Natal 19 Chewable Information

  • SPL UNCLASSIFIED SECTION

    A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation

    Rx Only


  • 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 Facts
    ​Servings per Bottle:​ 100 ​%DV For Pregnant and Lactating Women
    ​Serving Size 1 chewable tablet
    ​Each Tablet contains:

    Vitamin A (as beta carotene)

    1000 IU 23%
    Vitamin C (calcium ascorbate) 100 mg 83%
    Vitamin D (as cholecalciferol) 10 mcg 67%
    Vitamin E (as dl-alpha tocopherol acetate) 30 IU 142%
    Thiamine (Vitamin B1) 3 mg 214%
    Riboflavin (Vitamin B2​) 3 mg 188%
    Niacin (as niacinamide) 15 mg 83%
    Vitamin B6 (as pyridoxine HCl) 20 mg 1000%
    Folate (folic acid) 1000 mcg 167%
    Vitamin B12​ (as cyanocobalamin) 12 mcg 429%
    Pantothenic Aicd (as calcium pantothenate) 7 mg 100%
    Calcium (as calcium carbonate) 200 mg 15%
    Iron (as ferrous fumarate) 29 mg 107%
    Zinc (as zinc oxide) 20 mg 154%


  • ​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 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 erythropoiesis. 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 megablastic macrocytic anemias. Vitamin B​12​ is essential to growth cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.


  • ​OTHER INGREDIENTS

    Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.


  • 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.


  • 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.


  • PRECAUTIONS

    GENERAL

    Take 2 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.


  • ​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.


  • DRUG INTERACTIONS

    Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.


  • 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.


  • DOSAGE AND ADMINISTRATION

    One tablet daily, or as directed by a physician.


  • NOTICE

    Contact with moisture can discolor or erode the tablet.


  • 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


  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)[See USP controlled room temperature].


  • 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.

    Reserved for Professional

    Recommendation.

    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

    Code 117-01

    Rev. 03/18

    SETON PHARMACEUTICALS


  • 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

    PRINCIPAL DISPLAY PANEL - 100 tablets


  • INGREDIENTS AND APPEARANCE
    SE-NATAL 19 CHEWABLE 
    vitamins and minerals tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-117
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 1000 [iU]
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 7 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 29 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ORANGE JUICE (UNII: 5A9KE2L9L3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 12mm
    Flavor ORANGE Imprint Code TL015
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13925-117-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/01/2009
    Labeler - Seton Pharmaceuticals (828898002)
    Registrant - Seton Pharmaceuticals (828898002)
    Establishment
    Name Address ID/FEI Business Operations
    VIVA PHARMACEUTICAL INC. 253288898 manufacture(13925-117)