Label: PRE-TABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous- ii bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
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Contains inactivated NDC Code(s)
NDC Code(s): 48948-406-30 - Packager: DEREMETRX LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated September 15, 2013
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- DESCRIPTION
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INDICATIONS & USAGE
Indications and Usage: Pre-Tabs DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. Pre-Tabs DHA is also beneficial in improving the nutritional status of women prior to conception.
- CONTRAINDICATIONS
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WARNINGS
Warnings: Ingestion of more than 3 grams of omega-fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
- WARNINGS
- BOXED WARNING (What is this?)
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PRECAUTIONS
Precautions: Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects. Do not take more than the recommended amount. If you are pregnant, nursing, or taking any medications consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. Not intended for use by persons under the age of 18.
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRE-TABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48948-406 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48948-406-30 6 in 1 CARTON 1 1 in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 PACKAGE 5 Part 2 5 PACKAGE 5 Part 1 of 2 PRE-TABS DHA MULTI-VITAMIN/MINERAL SUPPLEMENT
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, polysaccharide iron complex, potassium iodide, zinc oxide, choline bitartrate tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) SODIUM ASCORBATE 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 450 [iU] TOCOPHERSOLAN (UNII: O03S90U1F2) (TOCOPHERSOLAN - UNII:O03S90U1F2) TOCOPHERSOLAN 30 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 50 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 10 ug CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 155 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 45 mg FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 32 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 100 ug ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 mg CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE 55 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) TALC (UNII: 7SEV7J4R1U) MALTODEXTRIN (UNII: 7CVR7L4A2D) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARNAUBA WAX (UNII: R12CBM0EIZ) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color blue (LIGHT BLUE) Score 2 pieces Shape OVAL Size 18mm Flavor Imprint Code WC;001 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2014 Part 2 of 2 NESTABS ABC OMEGA 3-DHA
doconexent and icosapent supplement capsule, gelatin coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 230 mg ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 30 mg ALPHA-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) ALPHA-TOCOPHEROL, D- 2 [iU] Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score no score Shape capsule Size 6mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/15/2014 Labeler - DEREMETRX LLC (079203275) Registrant - DERMETRX LLC (079203275)