Label: PNV PRENATAL PLUS MULTIVITAMIN- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, and cupric oxide tablet

  • NHRIC Code(s): 44946-1045-1, 44946-1045-4, 44946-1045-9
  • Packager: Agile RX
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 7, 2023

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet
    Servings Per Container: 100
    Amount per serving% Daily Value
    Vitamin A (from Acetate and Beta Carotene)4000 IU50%
    Vitamin C (Ascorbic Acid)120 mg200%
    Vitamin D-3 (Cholecalciferol)400 IU100%
    Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg50%
    Vitamin B-1 (from Thiamine Mononitrate)1.84 mg108%
    Vitamin B-2 (Riboflavin)3 mg150%
    Niacin (as Niacinamide)20 mg100%
    Vitamin B-6 (from Pyridoxine HCl)10 mg400%
    Folic Acid1 mg125%
    Vitamin B-12 (Cyanocobalamin)12 mcg150%
    Calcium (as Calcium Carbonate)200 mg15%
    Iron (from Ferrous Fumarate)27 mg150%
    Zinc (from Zinc Oxide)25 mg167%
    Copper (from Cupric Oxide)2 mg100%

    OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc, Magnesium Stearate.

  • HEALTH CLAIM

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

  • DIRECTIONS

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

  • TAMPER EVIDENT FEATURE

    Do not use if inner-seal beneath cap is missing or broken.

  • WARNINGS

    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.
  • CAUTION

    Folic Acid may mask the symptoms of hematological damage due to Vitamin B12 deficiency of pernicious anemia while the associated neurological damage progresses.

  • Other Information

    To report a serious adverse event or obtain product information, call 1-888-750-5290. 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.

  • SAFE HANDLING WARNING

    IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

  • HEALTH CLAIM

    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 with the FDA.

    †The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

    ‡THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
  • HEALTH CLAIM

    Manufactured for:
    Agile RX LLC
    Boynton Beach, FL 33437
    (888) 750-5290

    Made in the USA

    LOT/EXP
    REV 05/02/19

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    44946-1045-1

    PNV Prenatal Health
    PNV
    Prenatal Vitamins

    Prenatal Plus
    MULTIVITAMIN
    Tablets

    Dispense under a
    physician's order†

    Provides vitamin and
    mineral supplementation
    throughout pregnancy and
    postnatal period‡

    Dietary Supplement

    Sugar & Gluten Free

    100
    TABLETS

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PNV PRENATAL PLUS MULTIVITAMIN 
    vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, and cupric oxide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1045
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2000 [iU]
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE2000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-22 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1045-1100 in 1 BOTTLE, PLASTIC
    2NHRIC:44946-1045-430 in 1 BOTTLE, PLASTIC
    3NHRIC:44946-1045-9500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement04/01/2013
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)19 mm
    imprint
    Labeler - Agile RX (116742427)
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