CyFolex by Key Therapeutics, LLC Cyfolex

CyFolex by

Drug Labeling and Warnings

CyFolex by is a Other medication manufactured, distributed, or labeled by Key Therapeutics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CYFOLEX- cholecalciferol, folic acid, calcium carbonate, and bovine type i collagen capsule 
Key Therapeutics

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Cyfolex

Supplement Facts

Serving Size: 1 Capsule
Servings per container: 30
Amount Per Serving:% Daily Value
Vitamin D3 (as cholecalciferol)800 IU200%
Folic Acid1 mg250%
Calcium (as calcium carbonate)50 mg5%
Cyplexinol® Nature's BMP – a Complex Partially Hydrolyzed collagen and its associated proteins Including Bone Morphogenetic Proteins (BMPs)
300 mg

*

* Daily Values (DV) not established.

OTHER INGREDIENTS

cellulose, magnesium stearate, and silicon dioxide.

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.

CONTRAINDICATIONS

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

WARNINGS

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

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

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.

DOSAGE AND ADMINISTRATION

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

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.

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.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident

Do not use if seal is broken or missing.

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.

PRINCIPAL DISPLAY PANEL

- 30 Capsule Bottle Label 70868-100-30

CyFolex Capsules

KEY

therapeutics

Dispensed by Prescription

30 Capsules

Revised: 1/2017       Key Therapeutics, LLC

PRINCIPAL DISPLAY PANEL
- 30 Capsule Bottle Label 70868-100-30
CyFolex Capsules
KEY
therapeutics
Dispensed by Prescription
30 Capsules

CYFOLEX 
cholecalciferol, folic acid, calcium carbonate, and bovine type i collagen capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70868-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION50 mg
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) (BOVINE TYPE I COLLAGEN - UNII:FHJ3ATL51C) BOVINE TYPE I COLLAGEN300 mg
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70868-100-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT01/09/201712/31/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)15 mm
Labeler - Key Therapeutics (080318791)

Revised: 12/2019
 

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