Label: PNV-SELECT- vitamin a acetate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, film coated

  • NDC Code(s): 42192-320-90
  • Packager: Acella Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    DESCRIPTION: PNV-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with “320” on one side.

    table

    OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).

  • INDICATIONS & USAGE

    INDICATIONS: PNV-Select is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

  • CONTRAINDICATIONS

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

  • 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 reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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

  • PRECAUTIONS

    PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

  • HOW SUPPLIED

    HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

  • STORAGE AND HANDLING

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

  • SPL UNCLASSIFIED SECTION

    All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein.

    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.

    MANUFACTURED FOR:

    Acella Pharmaceuticals, LLC

    Alpharetta, GA 30005

    1-800-541-4802

    Rev 0719-03

  • PRINCIPAL DISPLAY PANEL - Film Coated Tablets

    NDC 42192-320-90

    PNV-Select

    Prenatal Multivitamin

    Dietary Supplement

    Film Coated Tablets

    Rx Only 90 Tablets

    Acella
    PHARMACEUTICALS, LLC

    PNV- Select

  • INGREDIENTS AND APPEARANCE
    PNV-SELECT 
    vitamin a acetate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID80 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID6 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION120 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION30 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 ug
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 320
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-320-9090 in 1 BOTTLE; Type 0: Not a Combination Product11/04/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/1990
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-320)