Cyfolex

CYFOLEX
(cholecalciferol, folic acid, calcium carbonate, and bovine type i collagen) Capsule

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.

INDICATIONS

No Information Provided

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 childresistant bottle of 30ct. (70868-100-30¹)

¹Key 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.

Manufactured for: Key Therapeutics, LLC Naples, FL 34102. MADE IN CANADA. Revised: Jan 2017.

SIDE EFFECTS

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.

DRUG INTERACTIONS

No Information Provided

WARNINGS

Included as part of the "PRECAUTIONS" Section

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.

OVERDOSE

No Information Provided

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

No Information Provided

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.