Supplement Facts

* 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