FIBRIK- .alpha.-tocopherol acetate, dl-, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, cyanocobalamin, thioctic acid, and ubidecarenone capsule
Key Therapeutics
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Fibrik Capsules
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Capsule | Servings per container: 30 | |
| Amount Per Serving: | % Daily Value | |
|
||
| Vitamin E (as dl-alpha tocopheryl acetate) | 15 IU | 50% |
| Thiamin (as thiamine HCl, Vitamin B1) | 15 mg | 500% |
| Vitamin B6 (as pyridoxine HCl) | 12.5 mg | 620% |
| Folic Acid | 1 mg | 250% |
| Vitamin B12 (as cyancobalamin) | 1 mg | 16,667% |
| Alpha lipoic Acid (ALA) | 150 mg | * |
| CoEnzyme Q-10 (ubiquinone) | 50 mg | * |
OTHER INGREDIENTS
cellulose, D&C Yellow #10, gelatin, magnesium stearate, silicon dioxide, titanium dioxide.
DESCRIPTION
Fibrik Capsules is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS
Fibrik 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 other medications.
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, Flowood, MS 39232.
DOSAGE AND ADMINISTRATION
Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.
HOW SUPPLIED
Fibrik Capsules are supplied as light yellow capsules imprinted with"105" in a child-resistant bottle of 30ct (70868-105-30)1
- 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.
Manufactured for:
Key Therapeutics, LLC
Flowood, MS 39232
MADE IN CANADA
Rev. 01/18
Dispensed by Prescription2
- 2
- 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).1-3 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.
- Federal Register Notice of August 2, 1973 (38 FR 20750)
- Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
- Federal Register Notice of March 5, 1996 (61 FR 8760)
| FIBRIK
.alpha.-tocopherol acetate, dl-, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, cyanocobalamin, thioctic acid, and ubidecarenone capsule |
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| Supplement Facts | ||
| Serving Size : | Serving per Container : | |
| Amount Per Serving | % Daily Value | |
|---|---|---|
| color | ||
| imprint | ||
| scoring | 1 | |
| shape | ||
| size (solid drugs) | 21 mm | |
| Labeler - Key Therapeutics (080318791) |