Gesticare DHA thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, doconexent, and icosapent kit |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:18860-253 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:18860-253-30 | 6 BLISTER PACK in 1 CARTON | | 1 | | 1 KIT in 1 BLISTER PACK | | 2 | NDC:18860-253-00 | 6 BLISTER PACK in 1 CARTON | | 2 | | 1 KIT in 1 BLISTER PACK | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | | 5 | | Part 2 | | 5 | | Part 3 | | 2 | | Part 4 | | 2 | |
| Part 1 of 4 | GESTICARE thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate tablet | |
| Product Information | | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | THIAMINE MONONITRATE (THIAMINE) | THIAMINE MONONITRATE | 3 mg | | RIBOFLAVIN (RIBOFLAVIN) | RIBOFLAVIN | 3 mg | | PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) | PYRIDOXINE HYDROCHLORIDE | 50 mg | | CYANOCOBALAMIN (CYANOCOBALAMIN) | CYANOCOBALAMIN | 8 ug | | ASCORBIC ACID (ASCORBIC ACID) | ASCORBIC ACID | 120 mg | | NIACIN (NIACIN) | NIACIN | 20 mg | | FOLIC ACID (FOLIC ACID) | FOLIC ACID | 1 mg | | FERROUS FUMARATE (IRON) | FERROUS FUMARATE | 27 mg | | CALCIUM CARBONATE (CARBONATE ION) | CALCIUM CARBONATE | 200 mg | | CHOLECALCIFEROL (CHOLECALCIFEROL) | CHOLECALCIFEROL | 410 [iU] | | .ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) | .ALPHA.-TOCOPHEROL ACETATE | 30 [iU] | | POTASSIUM IODIDE (IODINE) | POTASSIUM IODIDE | 150 ug | | ZINC OXIDE (ZINC OXIDE) | ZINC OXIDE | 15 mg | | CHOLINE BITARTRATE (CHOLINE) | CHOLINE BITARTRATE | 55 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | CROSCARMELLOSE SODIUM | | | SILICON DIOXIDE | | | MAGNESIUM STEARATE | | | CITRIC ACID MONOHYDRATE | | | TALC | | | MALTODEXTRIN | | | FD&C RED NO. 40 | | | TITANIUM DIOXIDE | | | STEARIC ACID | | | CELLULOSE, MICROCRYSTALLINE | | | STARCH, POTATO | | | CALCIUM SULFATE | | | GELATIN | | | SUCROSE | | | SOYBEAN OIL | | | CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | | | POLYVINYL ALCOHOL | | | POLYETHYLENE GLYCOLS | | | FD&C YELLOW NO. 6 | | | FD&C BLUE NO. 1 | | |
| Product Characteristics | | Color | pink (P-114, light, coated) | Score | no score | | Shape | CAPSULE (oblong) | Size | 19mm | | Flavor | | Imprint Code | | | Contains | | |
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| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 09/01/2009 | | |
| Part 2 of 4 | DHA doconexent and icosapent capsule, gelatin coated | |
| Product Information | | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | DOCONEXENT (DOCONEXENT) | DOCONEXENT | 250 mg | | ICOSAPENT (ICOSAPENT) | ICOSAPENT | 0.625 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | GELATIN | | | GLYCERIN | | | SUNFLOWER OIL | | | ASCORBYL PALMITATE | | | POLYSORBATE 80 | | | TOCOPHEROL | | |
| Product Characteristics | | Color | orange | Score | no score | | Shape | CAPSULE | Size | 14mm | | Flavor | | Imprint Code | | | Contains | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Dietary Supplement | | 09/01/2009 | | |
| Part 3 of 4 | GESTICARE thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate tablet | |
| Product Information | | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | THIAMINE MONONITRATE (THIAMINE) | THIAMINE MONONITRATE | 3 mg | | RIBOFLAVIN (RIBOFLAVIN) | RIBOFLAVIN | 3 mg | | PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) | PYRIDOXINE HYDROCHLORIDE | 50 mg | | CYANOCOBALAMIN (CYANOCOBALAMIN) | CYANOCOBALAMIN | 8 ug | | ASCORBIC ACID (ASCORBIC ACID) | ASCORBIC ACID | 120 mg | | NIACIN (NIACIN) | NIACIN | 20 mg | | FOLIC ACID (FOLIC ACID) | FOLIC ACID | 1 mg | | FERROUS FUMARATE (IRON) | FERROUS FUMARATE | 27 mg | | CALCIUM CARBONATE (CARBONATE ION) | CALCIUM CARBONATE | 200 mg | | CHOLECALCIFEROL (CHOLECALCIFEROL) | CHOLECALCIFEROL | 410 [iU] | | .ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) | .ALPHA.-TOCOPHEROL ACETATE | 30 [iU] | | POTASSIUM IODIDE (IODINE) | POTASSIUM IODIDE | 150 ug | | ZINC OXIDE (ZINC OXIDE) | ZINC OXIDE | 15 mg | | CHOLINE BITARTRATE (CHOLINE) | CHOLINE BITARTRATE | 55 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | CROSCARMELLOSE SODIUM | | | SILICON DIOXIDE | | | MAGNESIUM STEARATE | | | CITRIC ACID MONOHYDRATE | | | TALC | | | MALTODEXTRIN | | | FD&C RED NO. 40 | | | TITANIUM DIOXIDE | | | STEARIC ACID | | | CELLULOSE, MICROCRYSTALLINE | | | STARCH, POTATO | | | CALCIUM SULFATE | | | GELATIN | | | SUCROSE | | | SOYBEAN OIL | | | CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | | | POLYVINYL ALCOHOL | | | POLYETHYLENE GLYCOLS | | | FD&C YELLOW NO. 6 | | | FD&C BLUE NO. 1 | | |
| Product Characteristics | | Color | pink (P-114, light, coated) | Score | no score | | Shape | CAPSULE (oblong) | Size | 19mm | | Flavor | | Imprint Code | | | Contains | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 09/01/2009 | | |
| Part 4 of 4 | DHA doconexent and icosapent capsule, gelatin coated | |
| Product Information | | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | DOCONEXENT (DOCONEXENT) | DOCONEXENT | 250 mg | | ICOSAPENT (ICOSAPENT) | ICOSAPENT | 0.625 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | GELATIN | | | GLYCERIN | | | SUNFLOWER OIL | | | ASCORBYL PALMITATE | | | POLYSORBATE 80 | | | TOCOPHEROL | | |
| Product Characteristics | | Color | orange | Score | no score | | Shape | CAPSULE | Size | 14mm | | Flavor | | Imprint Code | | | Contains | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Dietary Supplement | | 09/01/2009 | | |
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| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 10/01/2008 | | |