FIBRIK- .alpha.-tocopherol acetate, dl-, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, cyanocobalamin, thioctic acid, and ubidecarenone capsule

Fibrik by

Drug Labeling and Warnings

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

Drug Details [pdf]

HEALTH CLAIM

Dispensed by Prescription

HEALTH CLAIM

Supplement Facts
Serving Size: 1 Capsule	Servings per container: 30
Amount Per Serving:		% Daily Value
* Daily Values (DV) not established.
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.

Pregnancy and Lactation

Fibrik Capsules are 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, 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.

Tamper Evident

Do not use if seal is broken or missing.

HEALTH CLAIM

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.

1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

Product Code 70868-105-30

Fibrik
Capsules

DIETARY SUPPLEMENT

KEY
therapeutics

Dispensed by Prescription

30 Capsules

INGREDIENTS AND APPEARANCE

FIBRIK 
.alpha.-tocopherol acetate, dl-, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, cyanocobalamin, thioctic acid, and ubidecarenone capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:70868-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	15 [iU]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	15 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	1 mg
THIOCTIC ACID (UNII: 73Y7P0K73Y) (THIOCTIC ACID - UNII:73Y7P0K73Y)	THIOCTIC ACID	150 mg
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	50 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:70868-105-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		01/03/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	21 mm
imprint

Labeler - Key Therapeutics, LLC (080318791)