TALIMENT- folic acid, pyridoxine hydrochloride, cyanocobalamin, ubiquinone, doconexent, icosapent, omega-3 fatty acids, and .beta.-sitosterol  capsule, coated 
Taleos Pharma

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TALIMENT Softgels

Rx Only

DESCRIPTION

TALIMENT is a prescription multi-vitamin in the form of a red, oblong softgel.

INDICATION AND USAGE

TALIMENT is a prescription multi-vitamin supplement with DHA and EPA that can be taken to improve nutritional status in conditions requiring Essential Fatty Acid, Vitamin B12 and B6 and Folic Acid supplementation capsule.

CONTRAINDICATIONS

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

WARNING

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PRECAUTIONS

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

Adults: One to four softgels orally daily or as directed by a physician.

Supplement Facts
Serving Size: 1 SoftgelServings per Container: 60
Amount Per Serving
Folic Acid 1mg
Vitamin B6 (as Pyridoxine HCl)15mg
Vitamin B12 (as Cyanocobalamin)0.5mg
Coenzyme Q10 (as Ubiquinone)50mg
Omega-3 Acids800mg
  Doconexent (DHA)350mg
  Icosapent (EPA)80mg
Beta-sitosterol200mg

STORAGE

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

Dispense in a well-closed, tight, light-resistant container as defined by the USP using a child resistant closure.

HOW SUPPLIED

TALIMENT softgels are supplied as red oblong, softgels. TALIMENT softgels are available in bottles of 60 (NDC: 70877-5776-6). Each tablet of TALIMENT contains 1 mg of Folic Acid , 15 mg of pyridoxine hydrochloride, 0.5 mg of cyanocobalamin, 50 mg of coenzyme Q10, 800 mg of omega-3 acids including 350 mg of Doconexent, 80 mg of Icosapent, and 200 mg of beta-sitosterol.

Distributed By:
Taleos Pharma Corp.
Eatontown, NJ 07724
www.taleos-pharma.com

TALIMENT and TALEOS are trademarks of Taleos Pharma Corp.

PRINCIPAL DISPLAY PANEL - 60 Softgel Bottle Label

70877-5776-6

TALIMENT

PRESCRIPTION
MULTI-VITAMINS

Rx Only        60 SOFTGELS

DIETARY SUPPLEMENT

Principal Display Panel - 60 Softgel Bottle Label
TALIMENT 
folic acid, pyridoxine hydrochloride, cyanocobalamin, ubiquinone, doconexent, icosapent, omega-3 fatty acids, and .beta.-sitosterol capsule, coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70877-5776
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE15 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.5 mg
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE50 mg
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS800 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT350 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT80 mg
.BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL200 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
WATER (UNII: 059QF0KO0R)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70877-5776-660 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT03/09/2018
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)24 mm
Labeler - Taleos Pharma (080318529)

Revised: 4/2018
Document Id: 163b880f-c76c-488a-87bd-5195fa665733
Set id: 0649c615-e995-44e2-8427-29982beff050
Version: 1
Effective Time: 20180406
 
Taleos Pharma