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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 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

  • INACTIVE INGREDIENTS

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


  • 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.


  • 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

    Folic acid in doses above 0.8 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.


  • DOSAGE AND ADMINISTRATION

    One tablet daily, or as directed by a physician.


  • 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


  • STORAGE

    Store at 20°-25°C (68°-77°F [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.


  • 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


  • 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
    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)