Label: NATACHEW- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, niacinamide tablet, chewable

  • NDC Code(s): 44118-902-05, 44118-902-90
  • Packager: Eckson Labs, LLC
  • 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 December 20, 2017

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

  • DESCRIPTION

    Supplement Facts

    Serving Size: 1 Tablet
    Amount Per Serving
    Vitamin A (beta carotene)2,700 IU
    Vitamin C (sodium ascorbate and ascorbic acid)120 mg
    Vitamin D 3 (cholecalciferol) 400 IU
    Vitamin E (dl-alpha tocopheryl acetate)20 IU
    Vitamin B 1 (thiamine mononitrate) 2 mg
    Vitamin B 2 (riboflavin) 3 mg
    Vitamin B 6 (pyridoxine HCl) 10 mg
    Folic Acid1 mg
    Vitamin B 12 (cyanocobalamin) 12 mcg
    Iron (ferrous fumarate and ferrous II bis-glycinate chelate)28 mg
    Niacinamide20 mg

    OTHER INGREDIENTS: sugar, D&C red #7 calcium lake, sucralose, flavor, microcrystalline cellulose, polyethylene glycol 400, stearic acid, magnesium stearate

  • INDICATIONS AND USAGE:

    NataChew ® is a prescription pre/post-natal multivitamin, multimineral indicated for use in improving the nutritional status of women throughout pregnancy, as well as in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS:

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

  • WARNINGS AND PRECAUTIONS:

    Folic acid is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs, and/or supplements should be considered.

    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.

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

  • ADVERSE REACTIONS:

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

  • DOSAGE AND ADMINISTRATION:

    One tablet daily with or without food or as prescribed by a physician.

  • HOW SUPPLIED:

    NataChew ® is supplied as a red tablet, imprinted “902”, in child-resistant bottles of 90 tablets, NDC 44118-902-90.

    Store between 15°C and 30°C (between 59°F and 86°F). Tamper evident by foil seal under cap.

    Manufactured for:

    Eckson Labs, LLC

    1000 N. West St., Suite 1200, #927
    Wilmington, DE 19801


    vM2 Rev. 04/2017 827453

  • PRINCIPAL DISPLAY PANEL

    label.jpg

  • INGREDIENTS AND APPEARANCE
    NATACHEW 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, niacinamide tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:44118-902
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE2700 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-20 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON28 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize13mm
    FlavorCHERRYImprint Code 902
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44118-902-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/2012
    2NDC:44118-902-059 in 1 CARTON10/15/2012
    25 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/15/2012
    Labeler - Eckson Labs, LLC (078435242)