truly SetonET-EC DHA Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement Dosage Form: tablets and softgel capsules Overview Side Effects Interactions Reviews Images More Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. SetonET-EC DHA R x Only Slideshow OTC Medication Use In Pregnancy: Wise or Worrisome? DESCRIPTION: SetonET-EC DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and enteric-coated softgel capsules. Each green oval SetonET-EC Tablet contains: VITAMINS A (beta carotene) 3,000 IU C (ascorbic acid) 120 mg D (cholecalciferol) 400 IU E (dl-alpha tocopheryl acetate) 3 mg B 1 (thiamine mononitrate) 1.8 mg B 2 (riboflavin) 4 mg Niacinamide 20 mg B 6 (pyridoxine HCI) 25 mg Folic acid 1 mg B 12 (cyanocobalamin) 12 mcg MINERALS Calcium (calcium carbonate) 200 mg Iron (ferrous bisglycinate HCl and iron protein succinylate) 29 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 25 mg Copper (cupric oxide) 2 mg Each frosted, clear, oval enteric-coated DHA softgel capsule contains: 430 mg purified omega-3 fatty acids including: At least 295 mg DHA (docosahexaenoic acid); also contains EPA (eicosapentaenoic acid) and other omega-3 fatty acids. OTHER INGREDIENTS (SetonET-EC Tablet): Ethyl Cellulose, FD&C Blue #1 Lake, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, Fumed Silica, Hypromellose, Iron Oxide Brown, Kollidon 30, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Talc, Titanium Dioxide, Vegetable Oil. OTHER INGREDIENTS (Enteric-coated DHA softgel capsule): Acetylated Monoglycerides, Ethyl Vanillin, Gelatin, Glycerin, Polysorbate 80, Potassium Sorbate, Purified Water, Shellac Ammonium Salt, Sodium Alginate, Specially Denatured Alcohol, Stearic Acid, Vitamin E. INDICATIONS: SetonET-EC DHA is a 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. SetonET-EC DHA is also useful in improving nutritional status prior to conception. CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil. WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. 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 a poison control center immediately. THIS PRODUCT CONTAINS FISH OIL. 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. PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). DRUG INTERACTIONS: Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized. ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and enteric-coated 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 1gram (1,000 mg) per day. HOW SUPPLIED: SetonET-EC DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 SetonET-EC tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 6 cards with 5 unit-doses per card which is a 30-day supply. SetonET-EC is a green oval tablet debossed with MVC-005 . The enteric-coated DHA softgel capsule is frosted colorless and oval. Unit dose blisters are child-resistant to opening as a safeguard against ingestion by children. NDC 13925-101-60 STORAGE: Store at USP controlled room temperature 20-25 C (68-77 F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN Rx Only Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Made In Canada 07/11 SETON PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules NDC 13925- 101 -60 SetonET-EC DHA Prenatal Vitamins Enteric-Coated R x Only 30-day supply - 30 tablets and 30 softgel capsules SETONET-EC beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide,omega-3 fatty acids kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-101 Packaging # Item Code Package Description 1 NDC:13925-101-60 1 KIT (1 KIT) in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 30 Part 2 30 Part 1 of 2 SETONET-EC beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide tablet Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 3 mg THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg FERROUS BISGLYCINATE HYDROCHLORIDE (FERROUS CATION) FERROUS CATION 29 mg MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES FD&C BLUE NO. 1 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 SILICON DIOXIDE HYPROMELLOSES BROWN IRON OXIDE POVIDONE K30 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 TALC TITANIUM DIOXIDE CORN OIL Product Characteristics Color GREEN Score no score Shape OVAL (OVAL) Size 19mm Flavor Imprint Code MVC005 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Part 2 of 2 SETONET-EC-DHA omega-3 fatty acids capsule, liquid filled Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 430 mg Inactive Ingredients Ingredient Name Strength DIACETYLATED MONOGLYCERIDES ETHYL VANILLIN GELATIN GLYCERIN POLYSORBATE 80 POTASSIUM SORBATE WATER SHELLAC SODIUM ALGINATE ALCOHOL STEARIC ACID ALPHA-TOCOPHEROL Product Characteristics Color YELLOW (Frosted colorless) Score no score Shape OVAL (OVAL) Size 23mm Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2009 11/30/2014 Labeler - Seton Pharmaceuticals (828898002) Revised: 01/2014 Seton Pharmaceuticals Print this page Add to My Med List More about multivitamin, prenatal Side Effects Drug Images Drug Interactions Support Group 60 Reviews Add your own review/rating Drug class: iron products Consumer resources Prenatal Vitamin Chewable Tablet ... +6 more Professional resources Other brands: Prenatal Plus , PreNexa , Prenatal 19 , Docosavit , ... +75 more Related treatment guides Vitamin/Mineral Supplementation during Pregnancy/Lactation} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Iron products Vitamin and mineral combinations Related Drugs iron products ferrous sulfate , Feosol Original , Iron-150 , Dialyvite vitamin and mineral combinations multivitamin , Citracal + D Vitamin / Mineral Supplementation during Pregnancy / Lactation ferrous sulfate , Feosol Original , Prenatal Multivitamins , Fergon , Ferrousal , FeroSul , Prenatal Plus , Slow Fe , Hemocyte , PreNexa , Prenatal 19 , Ferrocite , Stuart Prenatal with Beta Carotene , OB Complete , Docosavit , Prenatal H , Ferate , More... 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