Label: CYFOLEX- cholecalciferol, folic acid, calcium carbonate, and bovine type i collagen capsule

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

Drug Label Information

Updated January 12, 2017

If you are a consumer or patient please visit this version.

  • HEALTH CLAIM

    Dietary Supplement
    Dispensed by Prescription.

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  • HEALTH CLAIM

    Supplement Facts
    Serving Size: 1 Capsule Servings per container: 30
    Amount Per Serving: % Daily Value
    *
    Daily Values (DV) not established.
    Vitamin D3 (as cholecalciferol) 800 IU 200%
    Folic Acid 1 mg 250%
    Calcium (as calcium carbonate) 50 mg 5%
    Cyplexinol® Nature's BMP – a Complex Partially Hydrolyzed collagen and its associated proteins Including Bone Morphogenetic Proteins (BMPs) 300 mg *
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  • OTHER INGREDIENTS

    cellulose, magnesium stearate, and silicon dioxide.

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  • DESCRIPTION

    CyFolex Capsules is an orally administered prescription folic acid supplement for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required, and nutritional supplementation for maintenance of good bone and cartilage health is needed.

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  • CONTRAINDICATIONS

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

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  • WARNINGS AND PRECAUTIONS

    CyFolex Capsules should only be used under the direction and supervision of a licensed medical practitioner.

    Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

    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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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  • Pregnancy and Lactation

    CyFolex Capsules is not intended for use in pregnant or lactating patients.

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  • ADVERSE REACTIONS

    You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Key Therapeutics, LLC, Naples FL 34102 at 1-888-981-8337.

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  • DOSAGE AND ADMINISTRATION

    Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

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  • HOW SUPPLIED

    CyFolex Capsules are supplied as light yellow capsules, printed with "100" dispensed in a child-resistant bottle of 30ct. (70868-100-301)


    1
    Key Therapeutics, LLC does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
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  • STORAGE

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

    Protect from heat, light and moisture.

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  • HEALTH CLAIM

    KEEP OUT OF THE REACH OF CHILDREN.

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  • Tamper Evident

    Do not use if seal is broken or missing.

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  • HEALTH CLAIM

    Manufactured for:
    Key Therapeutics, LLC
    Naples, FL 34102
    MADE IN CANADA

    Dispensed by Prescription.

    Rev. 12/16

    This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

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  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    70868-100-30

    CyFolex
    Capsules

    KEY
    therapeutics

    Dispensed by
    Prescription

    30 Capsules

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CYFOLEX 
    cholecalciferol, folic acid, calcium carbonate, and bovine type i collagen capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:70868-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 800 [iU]
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 50 mg
    BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) (BOVINE TYPE I COLLAGEN - UNII:FHJ3ATL51C) BOVINE TYPE I COLLAGEN 300 mg
    Inactive Ingredients
    Ingredient Name Strength
    .ALPHA.-CELLULOSE (UNII: I355QGZ19A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:70868-100-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 01/09/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    scoring 1
    shape
    size (solid drugs) 15 mm
    imprint
    Labeler - Key Therapeutics, LLC (080318791)
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