NDC | 68025-039-30 |
Set ID | 4bbdc236-8211-4720-8fc8-fb6a7d6b2585 |
Category | DIETARY SUPPLEMENT |
Packager | Vertical Pharmaceuticals Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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PRESCRIBING INFORMATION
Supplement Facts Serving Size: 1 Chewable Tablet
Servings per Box:30For Pregnant and Lactating Women Amount per Serving % Daily Value - *
- DimaCal and TRAACS are registered trademarks of Albion Laboratories, Inc. Malates covered by U.S. Patent 6,706,904, Chelate covered by U.S. Patent 7,838,042; and patents pending.
- †
- Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah.
U.S. Pat. No. 6,716,814; U.S. Pat. No. 5,516,925; U.S. Pat. No. 8,007,846 and patents pending including: U.S. Pat. Appl. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028 - ‡
- DHA Sourced from Algae
- §
- Daily Value not established
Vitamin C (Ascorbic Acid and Sodium Ascorbate) 120 mg 200% Vitamin D3 (Cholecalciferol) 800 IU 200% Vitamin E (d-Alpha Tocopheryl Acetate) 30 IU 100% Vitamin B1 (Thiamine Mononitrate) 2 mg 118% Vitamin B2 (Riboflavin) 3 mg 150% Vitamin B3 (Niacinamide) 10 mg 50% Vitamin B6 (Pyridoxine HCl) 10 mg 400% Folic Acid 1 mg 125% Vitamin B12 (Cyanocobalamin) 15 mcg 188% Calcium (as DimaCal® di-Calcium Malate)* 20 mg 2% Ferronyl Carbonyl Iron (Elemental Iron) 15 mg 83% Sumalate®† (Ferrous Asparto Glycinate) 5 mg 28% Magnesium (as di-Magnesium Malate)* 1.2 mg 2% Zinc (as TRAACS® Zinc Glycinate Chelate)* 2 mg 13% DHA (Docosahexaenoic Acid)‡ 100 mg § - INDICATIONS
- CONTRAINDICATIONS
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PRECAUTIONS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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ADVERSE REACTIONS
Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
- WARNINGS
- DRUG INTERACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 30 Tablet Carton
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INGREDIENTS AND APPEARANCE
OB COMPLETE CHEWABLE
ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron pentacarbonyl, ferrous asparto glycinate, magnesium glycinate, zinc glycinate, and ulkenia dha oil tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:68025-039 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 50 mg Sodium Ascorbate (UNII: S033EH8359) (Ascorbic Acid - UNII:PQ6CK8PD0R) Sodium Ascorbate 70 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 800 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU] Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 2 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 3 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 10 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 10 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 15 ug CALCIUM MALATE (UNII: D48OP746DW) (CALCIUM MALATE - UNII:D48OP746DW) CALCIUM MALATE 20 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation 15 mg FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation 5 mg MAGNESIUM GLYCINATE (UNII: IFN18A4Y6B) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLYCINATE 1.2 mg ZINC GLYCINATE (UNII: 681VJX72FE) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation 2 mg ULKENIA DHA OIL (UNII: 4LA1OHZ06A) (ULKENIA DHA OIL - UNII:4LA1OHZ06A) ULKENIA DHA OIL 100 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Sorbitol (UNII: 506T60A25R) Sucrose (UNII: C151H8M554) Sucralose (UNII: 96K6UQ3ZD4) Stearic Acid (UNII: 4ELV7Z65AP) Magnesium Stearate (UNII: 70097M6I30) Citric Acid Monohydrate (UNII: 2968PHW8QP) Silicon Dioxide (UNII: ETJ7Z6XBU4) FD&C Blue No. 2 (UNII: L06K8R7DQK) Aluminum Oxide (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68025-039-30 5 in 1 CARTON 1 6 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 10/26/2012 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 2 shape size (solid drugs) 21 mm imprint flavor flavor Labeler - Vertical Pharmaceuticals Inc. (173169017)