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

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TALIVA Softgels

Rx Only

DESCRIPTION

TALIVA is a prescription multi-vitamin in the form of a red, opaque softgel.

INDICATION AND USAGE

TALIVA 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
*
AbsoFol™, under exclusive license, is trademark of Taleos Pharma Corp. (patents pending)
Folic Acid (as Folic Acid - AbsoFol™)*1mg
Vitamin B6 (as Pyridoxine HCl)12.5mg
Vitamin B12 (as Cyanocobalamin)0.5mg
Omega-3 Acids500mg
  Doconexent (DHA)350mg
  Icosapent (EPA)35mg
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

TALIVA softgels are supplied as red, opaque, oblong, coated softgels. TALIVA softgels are available in bottles of 60 (NDC: 70877-8588-01).

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

TALIVA, ABSOFOL and TALEOS are trademarks of Taleos Pharma Corp.

PRINCIPAL DISPLAY PANEL - 60 Softgel Bottle Label

70877-8588-1

TALIVA

PRESCRIPTION
MULTI-VITAMINS

WITH DHA/EPA

WITH 100%
AbsoFol

Rx Only

DIETARY SUPPLEMENT
60 Softgels

Principal Display Panel - 60 Softgel Bottle Label
TALIVA 
folic acid, pyridoxine hydrochloride, cyanocobalamin, doconexent, icosapent, omega-3 fatty acids, and .beta.-sitosterol capsule, gelatin coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70877-8588
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 Hydrochloride12.5 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin0.5 mg
Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent350 mg
Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent35 mg
Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids35 mg
.Beta.-Sitosterol (UNII: S347WMO6M4) (.Beta.-Sitosterol - UNII:S347WMO6M4) .Beta.-Sitosterol200 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin, Unspecified (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
White Wax (UNII: 7G1J5DA97F)  
Water (UNII: 059QF0KO0R)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Red NO. 40 (UNII: WZB9127XOA)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Tocopherol (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70877-8588-160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT11/01/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)25 mm
Labeler - Taleos Pharma (080318529)

Revised: 1/2018
Document Id: 5cd3312d-c14a-4f05-aa1d-89425c3b9430
Set id: b3d029f3-3f5e-4744-aff1-64fcaa991bd3
Version: 2
Effective Time: 20180105
 
Taleos Pharma