Label: DEXIFOL- ascorbic acid, folic acid, biotin, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and calcium pantothenate tablet, film coated
- NHRIC Code(s): 70877-1002-1
- Packager: Taleos Pharma
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated January 5, 2018
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- HEALTH CLAIM
- DESCRIPTION
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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
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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.
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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.
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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.
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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
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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Caplet Servings 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) 60mg 100% Folic Acid (as Folic Acid - AbsoFol™)* 5mg 1,250% D-Biotin 300mcg 100% Vitamin B1 (as Thiamine HCl) 1.5mg 100% Vitamin B2 (as Riboflavin) 1.5mg 88% Vitamin B3 (as Niacinamide) 20mg 100% Vitamin B6 (as Pyridoxine HCl) 50mg 2,000% Vitamin B12 (as Cyanocobalamin) 1mg 16,667% Pantothenic Acid (as Calcium Pantothenate) 10mg 100% - STORAGE
- HOW SUPPLIED
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Label
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INGREDIENTS AND APPEARANCE
DEXIFOL
ascorbic acid, folic acid, biotin, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and calcium pantothenate tablet, film coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:70877-1002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 5 mg Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin 300 ug Thiamine Hydrochloride (UNII: M572600E5P) (Thiamine ion - UNII:4ABT0J945J) Thiamine Hydrochloride 1.5 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.5 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 50 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 1 mg Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737, Calcium Cation - UNII:2M83C4R6ZB) Pantothenic Acid 10 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:70877-1002-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 11/01/2017 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 22 mm Labeler - Taleos Pharma (080318529)
