Label: PRENATAL 19- folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, and zinc oxide tablet, chewable

  • NDC Code(s): 42937-707-10
  • Packager: Nationwide Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 3, 2020

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  • DESCRIPTION

    PreNatal 19 chewable tablets are round, debossed "C43". These tablets provide oil-soluble vitamins and minerals.

    Each tablet has the following active ingredient:
    Folate (folic acid)1 mg
    Each tablet also contains the following ingredients for nutritional supplement:
    Vitamin A (as beta carotene)1000 IU
    Vitamin C (as ascorbic acid)100 mg
    Vitamin D (as cholecalciferol)400 IU
    Vitamin E (as dl-alpha-tocopheryl acetate)30 IU
    Thiamine (Vitamin B1)
      (thiamine mononitrate)3 mg
    Riboflavin (Vitamin B2)3 mg
    Niacin (as niacinamide)15 mg
    Vitamin B6 (as pyridoxine HCl)20 mg
    Vitamin B12 (as cyanocobalamine)12 mcg
    Pantothenic Acid (as calcium pantothenate)7 mg
    Calcium (as calcium carbonate)200 mg
    Iron (as ferrous fumarate)29 mg
    Zinc (as zinc oxide)20 mg

    OTHER INGREDIENTS:

    Flavors, magnesium stearate, maltodextrin, mannitol, silicon dioxide, stearic acid, sucralose and sucrose.

  • INDICATIONS

    PreNatal 19 chewable tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in postnatal period for both lactating and non-lactating mothers. PreNatal 19 chewable tablets are also useful in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS

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

  • WARNINGS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

  • 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.

  • PRECAUTIONS

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

  • HOW SUPPLIED

    PreNatal 19 chewable tablets for oral administration are supplied as multi-color-speckled,round tablets debossed "C43", packaged in bottles of 100 tablets.

    PHARMACIST

    Dispense in a tight, light–resistant container as defined in the USP/NF with child-resistant closure.

    STORAGE

    Store at 20°-25°C (68°-77°F) [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.

  • SPL UNCLASSIFIED SECTION

    Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision.

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Nationwide Laboratories LLC
    Iselin NJ 08830

    Lot No.: Exp. Date: Rev. 12/12

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Nationwide Laboratories LLC

    NDC 42937-707-10

    PreNatal 19
    Chewable Tablets

    A Prescription Prenatal Vitamin
    with other Vitamins and Minerals
    for Nutritional Supplementation

    Rx only

    100 Tablets

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PRENATAL 19 
    folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, and zinc oxide tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42937-707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE1000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE20 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID7 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 mg
    Inactive Ingredients
    Ingredient NameStrength
    magnesium stearate (UNII: 70097M6I30)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    mannitol (UNII: 3OWL53L36A)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorBROWN (multi-color-speckled) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code C43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42937-707-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/01/2013
    Labeler - Nationwide Laboratories, LLC (078366153)