Label: PRENAISSANCE PLUS- calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent capsule, liquid filled

  • NDC Code(s): 42192-343-30
  • 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 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION:

    Prenaissance Plus is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is purple in color, opaque and imprinted with "343" on one side.

    EACH SOFTGEL CONTAINS: 

     Calcium (Calcium citrate) 100 mg 
     Iron (Carbonyl Iron) 28 mg
     Vitamin D3 (Cholecalciferol)400 IU 
     Vitamin E (dl-alpha tocopherol acetate 30 IU
     Vitamin B6 (Pyridoxine HCI) 25 mg 
     Folic Acid 1 mg 
     Docusate Sodium50 mg  
     DHA (Docosahexaenoic acid) 250 mg

    OTHER INGREDIENTS:

    soybean oil, yellow bee's wax, lecithin, natural orange cream flavoring, gelatin, glycerine, purified water, carmine, titanium dioxide, ethyl vanillin, FD&C#40, and FD&C Blue #1.

  • INDICATIONS:

    Prenaissance Plus is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

  • CONTRAINDICATIONS:

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

  • WARNING:

    Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

  • 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.

  • 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:

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

  • CAUTION:

    Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) daily.

  • DOSAGE AND ADMINISTRATION:

    Usual adult dose is 1 (one) softgel daily or as directed by a physician.

  • NOTICE:

    Contact the moisture can discolor or erode the capsule.

  • HOW SUPPLIED:

    Prenaissance Plus is supplied in child-resistant bottles of 30 softgels (NDC# 42192-343-30).

    Store at 15° - 30°C (59° - 86°F) [See USP].

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

  • SPL UNCLASSIFIED SECTION

    All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please 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 active ingredients, excipients, inactive ingredients and chemical information provided herein.

    MANUFACTURED FOR:
    Acella Pharmaceuticals, LLC
    Alpharetta, GA 30009

  • PRINCIPAL DISPLAY PANEL - 30 Softgels

    NDC 42192-343-30

    Prenaissance Plus

    Rx Prenatal Vitamin and DHA

    Rx only              30 Softgels

    Acella
    PHARMACEUTICALS, LLC

    PRINCIPAL DISPLAY PANEL - 30 Softgels
  • INGREDIENTS AND APPEARANCE
    PRENAISSANCE PLUS 
    calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent capsule, liquid filled
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42192-343
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS 100 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION28 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]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code 343
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-343-3030 in 1 CAPSULE; Type 0: Not a Combination Product10/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER10/07/2011
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-343)
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