Label: PNV PRENATAL VITAMIN- .alpha.-tocopherol acetate, dl-, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, niacinamide, sodium ascorbate, ascorbic acid, pyridoxine hydrochloride, riboflavin, and thiamine mononitrate tablet, chewable

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated December 27, 2017

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  • STATEMENT OF IDENTITY

    PNV Chewable Tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both the lactating and non-lactating mothers, and is useful for improving nutritional status prior to conception.

  • STATEMENT OF IDENTITY

    Each fruit-flavored PNV Chewable tablet contains:

    VITAMINS:
    Vitamin C (as sodium ascorbate and ascorbic acid)120 mg
    Vitamin D3 (as cholecalciferol)400 IU
    Vitamin E (as dl-alpha tocopheryl acetate)11 IU
    Vitamin B1 (as thiamin mononitrate)2 mg
    Vitamin B2 (as riboflavin)3 mg
    Vitamin B3 (as niacinamide)20 mg
    Vitamin B6 (as pyridoxine HCL)10 mg
    Vitamin Folic Acid1 mg
    Vitamin B12 (as cyanocobalamin)12 mcg
    MINERAL:
    Iron (as ferrous fumarate)29 mg

    OTHER INGREDIENTS

    Microcrystalline cellulose, xylitol, magnesium stearate, talc, natural fruit flavor, malic acid, sucralose, citric acid, and mixed tocopherols.

  • DIRECTIONS

    One tablet daily with a meal, or as directed by a physician. Tablets should be chewed or crushed before swallowing.

  • CAUTION

    Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

  • 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.

  • ADVERSE REACTIONS

    In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy.

  • HOW SUPPLIED

    PNV Prenatal Health™ - Prenatal Vitamins are light brown to brown-speckled, fruit-flavored, round tablets debossed "SCI" on one side.

    STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F).

    PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure.

  • HEALTH CLAIM

    This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA.

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

    DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

    Manufactured by: Sancilio & Company, Inc.,
    Riviera Beach, FL 33404
    (800) SCI-8711

    © 2011 Sancilio & Company, Inc.

    REV: 12/06/11

  • PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label

    44946-1041-5

    PNV Prenatal Health
    PNV
    Prenatal Vitamins

    FOLIC ACID + IRON
    MULTIVITAMIN
    Chewable
    Tablets

    Dispense under a
    physician's order†

    Dietary Supplement

    Sugar Free

    SCI
    Sancilio & Company, Inc
    Developing Good Science into Great Medicine

    90
    TABLETS

    PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label
  • INGREDIENTS AND APPEARANCE
    PNV PRENATAL VITAMIN 
    .alpha.-tocopherol acetate, dl-, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, niacinamide, sodium ascorbate, ascorbic acid, pyridoxine hydrochloride, riboflavin, and thiamine mononitrate tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL-11 [iU]
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
    Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous cation - UNII:GW89581OWR) Ferrous cation29 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
    Sodium Ascorbate (UNII: S033EH8359) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine10 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin3 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine2 mg
    Inactive Ingredients
    Ingredient NameStrength
    Xylitol (UNII: VCQ006KQ1E)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Malic Acid (UNII: 817L1N4CKP)  
    Talc (UNII: 7SEV7J4R1U)  
    Magnesium stearate (UNII: 70097M6I30)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1041-590 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/20/2011
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)16 mm
    imprint
    flavor
    Labeler - Sancilio & Company Inc (176681257)
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