Dosage and administration
Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.
CyFolex Capsules
- Manufacturer
- Key Therapeutics, LLC
- Effective date
- 2017-01-12
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:20:42
Label at a glance#
ProductCyFolex
Active ingredientCHOLECALCIFEROL, Folic Acid, CALCIUM CARBONATE, BOVINE TYPE I COLLAGEN
Label structure15 sections
Contacts and useful links#
Label contents#
Full prescribing information#
HEALTH CLAIM SECTION
Dietary Supplement
Dispensed by Prescription.
HEALTH CLAIM SECTION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Capsule | Servings per container: 30 | |
| Amount Per Serving: | % Daily Value | |
| 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 | * |
* 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 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
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. (70868-100-302)
2 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.
HEALTH CLAIM SECTION
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident
Do not use if seal is broken or missing.
HEALTH CLAIM SECTION
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70868-100-30 | EA - Each | 70868-100 | 00687d19-9b11-4d88-b241-dd64541d2a04 | 1 | 2017-03-06 |
Products#
Every source-derived product name is available through these pages.
- CyFolex
- CHOLECALCIFEROL, FOLIC ACID, CALCIUM CARBONATE, and BOVINE TYPE I COLLAGEN
- CHOLECALCIFEROL
- Folic Acid
- CALCIUM CARBONATE
- CALCIUM CATION
- BOVINE TYPE I COLLAGEN
- .ALPHA.-CELLULOSE
- MAGNESIUM STEARATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70868-100 | 70868-100-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| Folic Acid | 935E97BOY8 | ACTIB |
| CALCIUM CARBONATE | H0G9379FGK | ACTIM |
| BOVINE TYPE I COLLAGEN | FHJ3ATL51C | ACTIB |
| .ALPHA.-CELLULOSE | I355QGZ19A | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.