Label: CYFOLEX- cholecalciferol, folic acid, calcium carbonate, and bovine type i collagen capsule
- NHRIC Code(s): 70868-100-30
- Packager: Key Therapeutics, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated January 12, 2017
If you are a consumer or patient please visit this version.
- 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 *
- OTHER INGREDIENTS
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.
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.
- Pregnancy and Lactation
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
CyFolex Capsules are supplied as light yellow capsules, printed with "100" dispensed in a child-resistant bottle of 30ct. (70868-100-301)
- 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.
- HEALTH CLAIM
- Tamper Evident
Key Therapeutics, LLC
Naples, FL 34102
MADE IN CANADA
Dispensed by Prescription.
†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.
- PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
INGREDIENTS AND APPEARANCE
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)