Label: PRENATAL PLUS MULTIVITAMIN PLUS DHA MINICAPS- vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil kit

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 7, 2023

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  • STATEMENT OF IDENTITY

    PRENATAL VITAMINS
    Supplement Facts
    Serving Size: 1 Tablet
    Servings Per Container: 30
    Amount per serving% Daily Value
    OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc and Magnesium Stearate.
    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 Acid
    Folate    		1 mg
    1700 mcg DFE    		212%
    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%
    DHA* MINICAPS®
    Supplement Facts
    Serving Size: 1 MiniCap®
    Servings Per Container: 30
    Amount per serving% Daily Value
    *Refers to Percent daily Value (%DV) based on a 2000 calorie diet.
    *DHA as Ethyl Esters
    †Daily Value not established.
    OTHER INGREDIENTS: Fish Oil, Gelatin, Water, Glycerin, Orange Oil and Mixed Tocopherols.
    Calories5
      Calories from Fat5
    Total Fat0.4 g3%
      Saturated Fat0 g0%
      Polyunsaturated Fat<2 mg†
      Monounsaturated Fat3 IU†
    Cholesterol<2 mg0%
    Vitamin E3 IU10%
    Total Omega-3 Fatty Acids312 mg†
    DHA*(Docosahexaenoic Acid)250 mg†
  • HEALTH CLAIM

    PNV Prenatal Plus Multivitamin tablets and DHA* MiniCaps® 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.‡

    In addition, the vital fatty acids in DHA* support brain, eye and nervous system development of your unborn child.‡

    Safe easy-to-swallow MiniCaps® have no fishy odor or aftertaste.

  • DOSAGE AND ADMINISTRATION

    Before, during and after pregnancy, swallow 1 PNV Plus tablet and 1 DHA* MiniCap® SoftGel daily, 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 15º-30ºC (59º-86ºF). Protect from excess heat and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.

  • HEALTH CLAIM

    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

    LOT/EXP

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

    REV 05/05/19
    Manufactured in the USA

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    44946-2001-6

    PNV Prenatal Health
    PNV
    Prenatal Vitamins

    Prenatal Plus
    MULTIVITAMIN
    Tablets
    +
    DHA*
    MINICAPS®

    Dispense under a
    physician's order†

    Provides vitamin and
    mineral supplementation
    throughout pregnancy and
    postnatal period‡

    Dietary Supplement

    Mercury Free
    Sugar & Gluten Free

    UNIT DOSE PACK
    30 TABLETS AND 30 MINICAPS®

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    PRENATAL PLUS MULTIVITAMIN PLUS DHA MINICAPS 
    vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil kit
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-2001
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-2001-61 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 30 
    Part 21 BLISTER PACK 30 
    Part 1 of 2
    PRENATAL PLUS MULTIVITAMIN 
    vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, and niacinamide tablet
    Product Information
    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
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE200 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
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE (UNII: 029TFK992N)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement11/15/2016
    Part 2 of 2
    DHA MINICAPS 
    fish oil capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F) FISH OIL312 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement11/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement11/15/2016
    Labeler - Agile RX (116742427)
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