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Se-Natal 19 (Seton Pharmaceuticals)

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TABLET 100 TABLET in 1 BOTTLE (13925-116-01) Label Information

Complete Se-Natal 19 Information

  • SPL UNCLASSIFIED SECTION

    Vitamins & Minerals with Folic Acid

    Rx Only


  • DESCRIPTION

    Se-Natal 19 provides oil soluble vitamins, water-soluble vitamins and minerals.

    Each tablet contains:
    Vitamin A (as beta carotene) 1000 IU
    Vitamin C (ascorbic acid) 100 mg
    Vitamin D (as cholecalciferol) 400 IU
    Vitamin E (as dl-alpha tocopheryl acetate) 30 IU
    Thiamine (Vitamin B1) 3 mg
    Riboflavin (Vitamin B2) 3 mg
    Niacin (as niacinamide) 15 mg
    Vitamin B6 (as pyridoxine HCI) 20 mg
    Folate (folic acid) 1 mg
    Vitamin B12 (as cyanocobalamin) 12 mcg
    Pantothenic Acid (as calcium pantothenate) 7 mg
    Calcium (as calcium carbonate) 200 mg
    Iron (as ferrous fumarate) 29 mg
    Zinc (as zinc oxide) 20 mg
    Docusate Sodium 25 mg

  • OTHER INGREDIENTS

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


  • 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.


  • 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 0.1 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 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019", packaged in bottles of 100 tablets.

    NDC 13925-116-01.


  • STORAGE

    Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.


  • PHARMACIST

    Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.

    Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.


  • SPL UNCLASSIFIED SECTION

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

    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

    Rev. 02/14

    SETON PHARMACEUTICALS


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 13925-116-01

    Se-Natal 19
    Tablets

    Vitamins and Minerals with Folic Acid

    100 Tablets

    Rx Only

    SETON
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - 100 tablets

  • INGREDIENTS AND APPEARANCE
    SE-NATAL 19 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-116
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 1000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (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 mg
    THIAMINE (UNII: X66NSO3N35) (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
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 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
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA (UNII: 5C5403N26O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code TL019
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13925-116-01 100 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)
    Establishment
    Name Address ID/FEI Business Operations
    Viva Pharmaceutical Inc. 253288898 MANUFACTURE(13925-116)
    Establishment
    Name Address ID/FEI Business Operations
    Rainbow Gold 800695152 REPACK(13925-116)