NDC | 44118-750-05, 44118-750-30, 44118-751-30, 44118-752-30 |
Set ID | f7445e81-8ae7-47fb-81c0-6b14837edbe4 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Eckson Labs, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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Rx Only
DESCRIPTION:
This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acids, supplied as tablets and softgel capsules.
Each tablet contains:
Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving Vitamin A (beta carotene) 2,800 IU Vitamin C (ascorbic acid) 120 mg Vitamin D 3 (cholecalciferol) 640 IU Vitamin E (dl-alpha tocopheryl acetate) 15 mg Vitamin B 1 (thiamine mononitrate) 1.5 mg Vitamin B 2 (riboflavin) 2 mg Niacinamide 20 mg Vitamin B 6 (pyridoxine HCl) 50 mg Folic acid 1 mg Vitamin B 12 (cyanocobalamin) 12 mcg Calcium (calcium carbonate) 215 mg Iron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone ®) 25 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 25 mg Selenium (sodium selenate) 65 mcg Copper (cupric oxide) 1.8 mg Iodine (potassium iodide) 210 mcg Choline (choline bitartrate) 55 mg Other ingredients: microcrystalline cellulose, starch, silica, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C red no. 40 aluminum lake, FD&C blue no. 1 & no. 2 aluminum lake
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Each softgel capsule contains in a clear solution of 267 mg purified omega long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), DPA (docosapentaenoic acid) and ALA (alpha-linolenic acid):
Supplement Facts
Serving Size: 1 Softgel Capsule
Amount Per Serving Total omega long-chain fatty acids (as DHA, EPA, DPA and ALA) 267 mg Other ingredients: gelatin, rice bran oil, glycerin, purified water
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INDICATIONS:
This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status prior to conception.
- CONTRAINDICATIONS:
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WARNINGS:
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
Since daily ingestion of more than 3 grams per day of omega-3 fatty acids, including ALA (alpha-linolenic acid), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
KEEP OUT OF REACH OF CHILDREN.
- PRECAUTIONS:
- DRUG INTERACTIONS:
- ADVERSE REACTIONS:
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DOSAGE AND ADMINISTRATION:
Before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily or as directed by a physician. The tablet and softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
- HOW SUPPLIED:
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STORAGE:
Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Relative humidity not to exceed 65%. Protect from moisture, excessive heat and freezing. Note that contact with moisture may produce surface discoloration of the tablet.
To report a serious adverse event or obtain product information, call 1-855-899-4237.
www.DuetDHA.com
Manufactured for:
1000 N. West St., Suite 1200, #927
Wilmington, DE 19801Ferrazone ® is a registered trademark of AkzoNobel b v
827582 v1 Rev. 08/2017
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DUET DHA BALANCED
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline, omega-3 fatty acids kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44118-750 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44118-750-30 1 in 1 CARTON; Type 0: Not a Combination Product 10/30/2012 2 NDC:44118-750-05 1 in 1 CARTON; Type 0: Not a Combination Product 10/30/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 30 Part 2 1 BLISTER PACK 30 Part 1 of 2 DUET DHA BALANCED
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline tabletProduct Information Item Code (Source) NDC:44118-751 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 215 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 25 mg MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 25 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SODIUM SELENATE 65 ug CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1.8 mg IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 210 ug CHOLINE (UNII: N91BDP6H0X) (CHOLINE - UNII:N91BDP6H0X) CHOLINE 55 mg .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 2800 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 640 [iU] .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 15 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE 1.5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 2 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) Product Characteristics Color red (MAROON) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code 750 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44118-751-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/30/2012 Part 2 of 2 DUET DHA BALANCED
omega-3 fatty acids capsule, gelatin coatedProduct Information Item Code (Source) NDC:44118-752 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 267 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) RICE BRAN OIL (UNII: LZO6K1506A) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score no score Shape CAPSULE Size 21mm Flavor Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44118-752-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/30/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/30/2012 Labeler - Eckson Labs, LLC (078435242)