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

  • NDC Code(s): 42192-341-30
  • 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 Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side.

    EACH SOFTGEL CONTAINS:

     Vitamin C (ascorbic acid, USP) 28 mg
     Calcium (tricalcium phosphate, NF) 160 mg
     Iron (ferrous fumarate, USP) 29 mg
     Vitamin D3 (cholecalciferol, USP) 800 IU
     Vitamin E (d-alpha tocopherol, USP) 30 IU
     Vitamin B6 (pyridoxine HCl, USP) 25 mg
     Folic Acid, USP1.25 mg 
     DHA (docosahexaenoic acid)325 mg 
     Docusate Sodium, USP55 mg 

    OTHER INGREDIENTS:

    gelatin, glycerin, purified water, soybean oil, lecithin, yellow bees wax, natural creamy orange flavor, titanium dioxide, FD&C red #40, ethyl vanillin, FD&C yellow #5, FD&C blue #1.

  • INDICATIONS:

    Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

  • CONTRAINDICATIONS:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a physician.

  • 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.

  • HOW SUPPLIED:

    Prenaissance Capsules are supplied in child-resistant bottles of 30 softgels (NDC# 42192-341-30).

    Store at 20° - 25°C (68° - 77°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
    1-800-541-4802

    Rev. 0411

  • PRINCIPAL DISPLAY PANEL - 30 Softgels

    NDC 42192-341-30

    Prenaissance Capsules

    Rx Prenatal Vitamin and DHA

    Rx only              30 Softgels

    Acella
    PHARMACEUTICALS, LLC

    PRINCIPAL DISPLAY PANEL - 30 Softgels
  • INGREDIENTS AND APPEARANCE
    PRENAISSANCE 
    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:42192-341
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID28 mg
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION160 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.25 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT325 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM55 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code 341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-341-3030 in 1 CAPSULE; Type 0: Not a Combination Product06/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER06/13/2011
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939manufacture(42192-341)
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