NDC | 44118-803-30, 44118-805-30, 44118-807-30 |
Set ID | 9532f8de-115c-4f37-9148-2e6899800f65 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Eckson Labs, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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DESCRIPTION:
This product is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral and omega-3 fatty acids, supplied as tablets and softgel capsules.
Each tablet contains:
Supplement Facts
Serving Size: 1 TabletAmount Per Serving Vitamin A (beta carotene) 2,800 IU Vitamin C (ascorbic acid) 120 mg Vitamin D (cholecalciferol) 820 IU Vitamin E (dl-alpha tocopheryl acetate) 3 mg Vitamin B 1 (thiamine mononitrate) 1.8 mg Vitamin B 2 (riboflavin) 4 mg Niacinamide 20 mg Vitamin B 6 (pyridoxine hydrochloride) 50 mg Folic acid 1 mg Vitamin B 12 (cyanocobalamin) 12 mcg Calcium (calcium carbonate) 200 mg Iron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone ®) 25 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 25 mg Copper (cupric oxide) 2 mg Iodine 220 mcg 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 400 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid).
Supplement Facts
Serving Size: 1 Softgel CapsuleAmount Per Serving Total omega-3 long-chain fatty acids (as DHA and EPA) 400 mg OTHER INGREDIENTS: gelatin, glycerin, purified water
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INDICATIONS:
This product is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral and omega-3 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 B 12 is deficient.
Since daily ingestion of more than 3 grams per day of omega-3 fatty acids, including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), 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:
Eckson Labs, LLC
1000 N. West St., Suite 1200, #927
Wilmington, DE 19801Ferrazone® is a registered trademark of AkzoNobel b v
1800009 v1 Rev. 07/2018
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DUET DHA 400
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine, omega-3 fatty acids kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44118-807 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44118-807-30 1 in 1 CARTON; Type 0: Not a Combination Product 09/09/2011 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 Part 2 1 BOTTLE 30 Part 1 of 2 DUET
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine tabletProduct Information Item Code (Source) NDC:44118-803 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .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 820 [iU] .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 3 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.8 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg 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 CATION 200 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 25 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 25 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 220 ug Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color red (maroon) Score no score Shape CAPSULE (caplet) Size 20mm Flavor Imprint Code 800 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44118-803-30 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/09/2011 Part 2 of 2 DUET DHA
omega-3 fatty acids capsule, gelatin coatedProduct Information Item Code (Source) NDC:44118-805 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 400 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) ETHYL VANILLIN (UNII: YC9ST449YJ) Product Characteristics Color yellow Score no score Shape CAPSULE Size 16mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44118-805-30 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/09/2011 Labeler - Eckson Labs, LLC (078435242)