DEXIFOL- ascorbic acid, folic acid, biotin, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and calcium pantothenate tablet, film coated 
Taleos Pharma

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DEXIFOL Caplets

Rx Only

DESCRIPTION

DEXIFOL is a prescription multi-vitamin in the form of a dark yellow, film-coated, caplet.

INDICATION AND USAGE

DEXIFOL is a prescription multi-vitamin supplement that can be taken to improve nutritional status in conditions requiring dietary supplementation. DEXIFOL can also be used for the dietary management of individuals with distinct nutritional needs under a physician or healthcare provider's supervision for end stage failure, dialysis, hyperhomocysteinemia or inadequate dietary vitamin intake.

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.

DO NOT EXCEED RECOMMENDED DOSAGE.

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. The 1 mg of cyanocobalamin contained in DEXIFOL Caplets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. A safer upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing DEXIFOL Caplets.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or healthcare provider before using or continuing use of this medication.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with the use of pyridoxine hydrochloride. Mild transient diarrhea, polycynthemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling of swelling of the entire body has been associated with the use of cyanocobalamin.

DRUG INTERACTIONS

Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

DOSAGE AND ADMINISTRATION

Adults

One caplet taken orally daily or as directed by a physician.

DO NOT EXCEED RECOMMENDED DOSAGE.

Supplement Facts
Serving Size: 1 CapletServings per Container: 30
Amount Per Serving          % Daily Value
*
AbsoFol™, under exclusive license, is trademark of Taleos Pharma Corp. (patents pending)
DEXIFOL and TALEOS are trademarks of Taleos Pharma Corp.
  Vitamin C (as Ascorbic Acid)60mg100%
  Folic Acid (as Folic Acid - AbsoFol™)*5mg1,250%
  D-Biotin300mcg100%
  Vitamin B1 (as Thiamine HCl)1.5mg100%
  Vitamin B2 (as Riboflavin)1.5mg88%
  Vitamin B3 (as Niacinamide)20mg100%
  Vitamin B6 (as Pyridoxine HCl)50mg2,000%
  Vitamin B12 (as Cyanocobalamin)1mg16,667%
  Pantothenic Acid (as Calcium Pantothenate)10mg100%

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

HOW SUPPLIED

DEXIFOL caplets are supplied as dark yellow, oblong, film coated caplets. DEXIFOL caplets are available in bottles of 30 (NDC: 70877-1002-01).

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

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Label

70877-1002-1

DEXIFOL

PRESCRIPTION
MULTI-VITAMINS

WITH 100%
AbsoFol

Rx Only
30 CAPLETS

DIETARY SUPPLEMENT

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Label
DEXIFOL 
ascorbic acid, folic acid, biotin, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and calcium pantothenate tablet, film coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70877-1002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid5 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
Thiamine Hydrochloride (UNII: M572600E5P) (Thiamine ion - UNII:4ABT0J945J) Thiamine Hydrochloride1.5 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.5 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride50 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin1 mg
Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737, Calcium Cation - UNII:2M83C4R6ZB) Pantothenic Acid10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Hypromellose 2910 (15 mpa.s) (UNII: 36SFW2JZ0W)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Magnesium Silicate (UNII: 9B9691B2N9)  
Triacetin (UNII: XHX3C3X673)  
Magnesium Stearate (UNII: 70097M6I30)  
Mineral Oil (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70877-1002-130 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)22 mm
Labeler - Taleos Pharma (080318529)

Revised: 1/2018
Document Id: e27b414e-5c78-45e1-8530-f2b0ad5e06e6
Set id: 156a9958-b567-40a9-b583-5135e58bd601
Version: 2
Effective Time: 20180105
 
Taleos Pharma