Label: NEONATAL VITAMIN tablet

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated September 18, 2020

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  • STATEMENT OF IDENTITY

    SUPPLEMENT FACTS:

    Serving Size: One Tablet

    Each Tablet contains:

    Vitamin A (as acetate, beta carotene)

    1200 mcg

    Vitamin D3 (as cholecalciferol)

    10 mcg

    Vitamin E (as dl-alpha topcopheryl acetate )

    4.6 mg

    Vitamin C (Ascorbic acid )

    100 mg

    Vitamin B1 (as thiamine HCl)

    1.5 mg

    Vitamin B2 (as riboflavin)

    1.7 mg

    Vitamin B3 (as niacinamide)

    1.8 mg

    Vitamin B6 (as pyridoxine HCl)

    2.6 mg

    Folic acid

    800 mcg

    Vitamin B12 (as cyanocobalamin)

    4 mcg

    Iron  (as ferrous fumarate )

    27 mg

    Citrus bioflavonoids complex 50% bio flavonoids

    2 mg

    Calcium (as carbonate sulfate )

    263 mg

    Zinc (as zinc oxide )

    25 mg

    Boron (as boron citrate )

    0.2 mg

    Inositol

    5 mg

    Other Ingredients: Dibasic calcium phosphate, 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 )

  • WARNINGS

    WARNINGS

    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.

    DOSAGE & ADMINISTRATION

    As with any supplement, if you are pregnant, nursing, or taking medication, consult your doctor before use.

    The safe upper limit for daily intake of folic acid is 1000 mcg (1 mg).

    Do not take Prenatal with other multivitamin formulas unless recommended by your doctor.

    IMPORTANT INFORMATION

    Long-term intake of high levels of vitamin A (excluding that sourced from beta-carotene) may increase the risk of osteoporosis in adults. Do not take this product if taking other vitamin A supplements.

    Information for Patients

    Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

    Pediatric Use

    Not recommended for pediatric use.

  • HEALTH CLAIM

    HOW SUPPLIED

    NEONATAL VITAMIN ; available in bottles of 100 Tablets. 70898-105-01

    SAFE HANDLING WARNING

    Store at room temperature.
    Avoid excessive heat above 40°C (104°F.)

    QUESTIONS? COMMENTS?

    Manufactured for:
    NEOMED Pharmaceutical,
    Hauppauge, NY-11788.

    REV.:08/20

    Distributed by:
    AUM Pharmaceuticals,
    320 Oser Ave.

    Hauppauge, NY-11788.

    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.

  • PRINCIPAL DISPLAY PANEL

    100 Count

  • INGREDIENTS AND APPEARANCE
    NEONATAL VITAMIN 
    neonatal vitamin tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70898-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1200 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE4.6 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1.8 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2.6 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID800 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4 ug
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    INOSITOL (UNII: 4L6452S749) (INOSITOL - UNII:4L6452S749) INOSITOL5 mg
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O) CITRUS BIOFLAVONOIDS2 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM263 mg
    BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON0.2 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 GLYCOL 8000 (UNII: Q662QK8M3B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    SUCROSE (UNII: C151H8M554)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70898-105-011 in 1 PACKAGE
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/31/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)5 mm
    Labeler - NEOMED PHARMACEUTICAL (048388130)