Label: PNV PRENATAL VITAMIN PLUS VITAMIN A- .alpha.-tocopherol acetate, dl-, ascorbic acid, cholecalciferol, cyanocobalamin, folic acid, ferrous fumarate, calcium phosphate, dibasic, anhydrous, niacinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, and vitamin a acetate tablet

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

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Drug Label Information

Updated December 14, 2012

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  • SPL UNCLASSIFIED SECTION

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

  • DESCRIPTION

    Each PNV tablet contains:

    VITAMINS:
    Vitamin A (as acetate)2500 IU
    Vitamin C (as Ascorbic Acid)60 mg
    Vitamin D3 (as Cholecalciferol)400 IU
    Vitamin E (as Tocopheryl acetate)15 IU
    Vitamin B1 (as Thiamine Mononitrate)1.05 mg
    Vitamin B2 (as Riboflavin, USP)1.2 mg
    Niacin (as Niacinamide)13.5 mg
    Vitamin B6 (as Pyridoxine HCL)1.05 mg
    Folic Acid1 mg
    Vitamin B12 (as Cyanocobalamin)4.5 mcg
    MINERAL:
    Iron (as ferrous fumarate)27 mg
    Calcium (as Dibasic Calcium Phosphate)50 mg

    OTHER INGREDIENTS

    Microcrystalline Cellulose, Croscarmellose Sodium, Citric Acid, Talc and Magnesium Stearate.

  • DIRECTIONS

    One tablet daily with a meal, or as directed by a physician.

  • CAUTION

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

  • 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.

  • 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

    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.

  • SPL UNCLASSIFIED SECTION

    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: 12/07/12

  • PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label

    44946-1046-4
    Rx only

    PNV Prenatal Health
    PNV
    Prenatal Vitamins

    FOLIC ACID + IRON
    MULTIVITAMIN
    PLUS VITAMIN A
    Tablets

    Provides vitamin and
    mineral supplementation
    throughout pregnancy
    and postnatal period

    Sugar & Gluten Free

    SCI
    Sancilio & Company, Inc
    Developing good science into great medicine

    400
    TABLETS

    PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PNV PRENATAL VITAMIN  PLUS VITAMIN A
    .alpha.-tocopherol acetate, dl-, ascorbic acid, cholecalciferol, cyanocobalamin, folic acid, ferrous fumarate, calcium phosphate, dibasic, anhydrous, niacinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, and vitamin a acetate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:44946-1046
    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-15 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin4.5 ug
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous cation - UNII:GW89581OWR) Ferrous cation27 mg
    Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) Calcium Phosphate, Dibasic, Anhydrous50 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
    Vitamin A Acetate (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Croscarmellose sodium (UNII: M28OL1HH48)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Talc (UNII: 7SEV7J4R1U)  
    Magnesium stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorBROWN (Light brown to brown-speckled) Scoreno score
    ShapeOVAL (capsule-shaped) Size18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44946-1046-030 in 1 BOTTLE, PLASTIC
    2NDC:44946-1046-290 in 1 BOTTLE, PLASTIC
    3NDC:44946-1046-4400 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/07/2012
    Labeler - Sancilio & Company Inc (176681257)
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