that youngsters SetonET Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement Dosage Form: tablet 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 Rx Only DESCRIPTION: SetonET is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules. Each light green oblong SetonET Tablet* contains: VITAMINS A (beta carotene) 3,000 IU C (ascorbic acid) 120 mg D (cholecalciferol) 400 IU E (dl-alpha tocopheryl acetate) 30 mg B 1 (thiamine mononitrate) 1.8 mg B 2 (riboflavin) 4 mg Niacinamide 20 mg B 6 (pyridoxine hydrochloride) 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 translucent oblong 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 Tablet): Gum Arabic, PVP K30, Citric Acid, TriPotassium Citrate, Microcrystalline Cellulose, Fumed Silica, Magnesium Stearate, Croscarmellose Sodium, Hypromellose, Polyethylene Glycol, Ethyl Cellulose, Vegetable Oil, Polysorbate 80, Titanium Dioxide, Talc, FD&C Yellow #6 Lake, FD&C Blue #1 Lake, FD&C Yellow #5 Lake, Brown Iron Oxide. *USP Compliance: SetonET tablet is formulated in conformance with official U.S. Pharmacopeia (USP) standards of quality for potency, purity and dissolution. DHA softgel capsule complies with the standards and methods outlined in the CRN Voluntary Monograph for potency and purity. Slideshow Don't Believe The Hype: How Multivitamins Conquered The Land Of The Free INDICATIONS: SetonET 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 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. 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. 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 . 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 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: SetonET is supplied in a carton containing 30 tablets and 30 softgels in blister cards. SetonET is a light green oblong tablet imprinted with MVC-001 . The DHA softgel capsule is a translucent oblong softgel capsule. Unit dose blisters are child-resistant to opening, as a safeguard against ingestion by children. NDC 13925-100-60 . STORAGE: 20 -25 C (68 -77 F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations 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 Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA 06/10 SETON PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules NDC 13925- 100 -60 SetonET PRENATAL VITAMINS High potency nutrition with an easy-to-tolerate iron formulation, plus DHA, an Omega-3 fatty acid R x Only PRENATAL VITAMINS 30-Day Supply 30 Tablets and 30 Softgel Capsules SETON PHARMACEUTICALS SetonET 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:13925-100 Packaging # Item Code Package Description 1 NDC:13925-100-60 1 KIT (1 KIT) in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 6 Part 2 6 Part 1 of 2 SetonET 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 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- 30 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 CARBONATE 200 mg IRON (IRON) IRON 29 mg MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 25 mg ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength ACACIA POVIDONE K30 CITRIC ACID MONOHYDRATE POTASSIUM CITRATE ANHYDROUS CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE MAGNESIUM STEARATE CROSCARMELLOSE SODIUM HYPROMELLOSES POLYETHYLENE GLYCOLS ETHYLCELLULOSES CASTOR OIL CORN OIL POLYSORBATE 80 TITANIUM DIOXIDE TALC FD&C YELLOW NO. 6 FD&C BLUE NO. 1 FD&C YELLOW NO. 5 BROWN IRON OXIDE Product Characteristics Color GREEN (LIGHT GREEN) Score no score Shape OVAL (OVAL) Size 15mm Flavor Imprint Code MVC001 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 DHA SOFTGEL omega-3 fatty acids capsule, gelatin coated 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 ALPHA-TOCOPHEROL GELATIN GLYCERIN ETHYL VANILLIN WATER Product Characteristics Color yellow (TRANSLUCENT) Score no score Shape OVAL (OVAL) Size 21mm 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... Multivitamin, prenatal Rating 60 User Reviews 8.5 /10 60 User Reviews 8.5 Rate it! Multivitamin, prenatal Images Multivitamin, prenatal systemic (S 0260 ) View all images} } end result
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