Label: DALIVIT- ascorbic acid, folic acid, niacinamide, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, cyanocobalamin and calcium pantothenate capsule, coated
- NHRIC Code(s): 70877-8243-3
- Packager: Taleos Pharma
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated April 6, 2018
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- HEALTH CLAIM
INDICATION AND USAGE
DALIVIT is a prescription multi-vitamin supplement that can be taken to improve nutritional status in conditions requiring dietary supplementation. DALIVIT 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.
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.
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 DALIVIT Softgels 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 DALIVIT Softgels.
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.
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.
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
STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Softgel Servings per Container: 30 Amount Per Serving % Daily Value Vitamin C (as Ascorbic Acid) 100mg 167% Folic Acid 1mg 250% Vitamin B1 (as Thiamine HCl) 2mg 133% Vitamin B2 (as Riboflavin) 2mg 117% Vitamin B3 (as Niacinamide) 20mg 100% Vitamin B6 (as Pyridoxine HCl) 10mg 400% Vitamin B12 (as Cyanocobalamin) 1mg 16,667% Pantothenic Acid (as Calcium Pantothenate) 10mg 100%
DALIVIT softgels are supplied as red softgel. DALIVIT softgels are available in bottles of 30 (70877-8243-3). Each softgel of Dalivit contains 100 mg ascorbic acid, 1 mg of Folic Acid, 2 mg of thiamine hydrochloride, 2 mg of riboflavin, 20 mg of niacinamide, 10 mg of pyridoxine hydrochloride, 1 mg of cyanocobalamin, and 10 mg of calcium pantothenate.
Taleos Pharma Corp.
Eatontown, NJ 07724
- PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
INGREDIENTS AND APPEARANCE
ascorbic acid, folic acid, niacinamide, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, cyanocobalamin and calcium pantothenate capsule, coated
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:70877-8243 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 2 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 2 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 10 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:70877-8243-3 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 03/09/2018 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 10 mm Labeler - Taleos Pharma (080318529)