Label: NEONATAL PLUS VITAMIN- neonatal plus vitamin tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 13, 2018

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

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  • STATEMENT OF IDENTITY

    Each prenatal tablet contains:

    Each Tablet contains:

    Vitamin A (as acetate, beta carotene)

    1200 mcg

    Vitamin D3 (as cholecalciferol)

    10 mcg

    Vitamin E (as dl-alpha topcopheryl acetate )

    9.2 mg

    Vitamin C (Ascorbic acid )

    20 mg 

    Vitamin B1 (as thiamine HCl)

    1.84 mg

    Vitamin B2 (as riboflavin)

    3 mg

    Vitamin B3 (as niacinamide)

    20 mg

    Vitamin B6 (as pyridoxine HCl)

    10 mg

    Folic acid

    1000 mcg

    Vitamin B12 (as cyanocobalamin)

    12 mcg

    Iron  (as ferrous fumarate )

    27 mg

    Citrus bioflavonoids complex 50% bio flavonoids

    2 mg

    Calcium (as carbonate sulfate )

    200 mg

    Zinc (as zinc oxide )

    25 mg

    Copper (as cupric oxide)

    2 mg

    Boron (as boron citrate )

    0.2 mg

    Inositol

    5 mg

    Other Ingredients: , microcrystalline  croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide (as color), polyethylene glycol, sucrose, magnesium stearate, talc,triacetin, HPMC E15,HPMC E5/E6,FD&C RED #40 (LAKES),FD&C YELLOW # 6 (LAKE )

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  • INDICATIONS & USAGE

    NEONATAL PLUS TABLET  Rx is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

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  • CONTRAINDICATIONS

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

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  • WARNINGS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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  • PRECAUTIONS

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    To report a serious adverse event or obtain product information, call 631-524-5758

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  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

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  • HOW SUPPLIED

    Bottles of 100 tablets each - NDC 70898-115-01

    STORAGE

    Store at 20-25°C (68-77°F) [See USP controlled room temperature].

    To report a serious adverse event or obtain product information, call 631-524-5758

    Distributed by:

    Neomed Pharmaceutical ,80 Cain Dr, Brentwood,NY 11717

    Phone :631-524-5758

    Email: info@neomedpharmaceutical.com

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  • INGREDIENTS AND APPEARANCE
    NEONATAL PLUS VITAMIN 
    neonatal plus vitamin tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70898-115
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1200 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 20 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 9.2 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1000 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg
    INOSITOL (UNII: 4L6452S749) (INOSITOL - UNII:4L6452S749) INOSITOL 5 mg
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O) CITRUS BIOFLAVONOIDS 2 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM 200 mg
    BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON 0.2 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    SUCROSE (UNII: C151H8M554)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color brown (BEIGE/PEACH) Score no score
    Shape CAPSULE (Caplet) Size 5mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70898-115-01 1 in 1 PACKAGE 07/31/2018
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/31/2018
    Labeler - NEOMED PHARMACEUTICAL (048388130)
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