delight UltimateCare ONE NF Generic Name: prenatal vitamin supplement Dosage Form: capsule Side Effects Dosage Professional Interactions Reviews More 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. UltimateCare ONE NF A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid. R x Only Slideshow Breastfeeding and OTC Medication: Safety Tips That You Need To Know UltimateCare ONE NF Description UltimateCare ONE NF is a prescription prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each maroon soft gelatin capsule for oral administration contains: * Vitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Essential Fatty Acids: Omega-3 Fatty Acids 500 mg Docosahexaenoic Acid (DHA) 350 mg Eicosapentaenoic Acid (EPA) 100 mg α-Linolenic Acid ( ALA) 50 mg Vitamins : Vitamin C Complex * (as calcium ascorbate and calcium threonate) 25 mg Vitamin D 3 (cholecalciferol) 800 IU Vitamin E (dl-alpha-tocopheryl acetate) 15 IU Vitamin B 2 (riboflavin, USP) 1.5 mg Vitamin B 3 (niacinamide) 10 mg Vitamin B 6 (pyridoxine hydrochloride) 50 mg Folic Acid, USP 1 mg Biotin 300 mcg Minerals: Calcium 100 mg Iron (elemental iron) Carbonyl iron 20 mg Ferrous Asparto Glycinate 7 mg Iodine 150 mcg Magnesium (magnesium oxide) 50 mg Zinc (zinc oxide, USP) 5 mg Other: Docusate Sodium 50 mg Inactive Ingredients: Gelatin, Glycerin, Purified Water, Yellow Bees Wax, Natural Creamy Orange Flavor, Lecithin, FD&C Red #40, Titanium Oxide, Ethyl Vanillin, FD&C Yellow #6, and FD&C Blue #1. INDICATIONS UltimateCare ONE NF is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception. Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Warnings Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. 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. THIS PRODUCT CONTAINS SOY. Precautions General Do not exceed recommended dosage. UltimateCare ONE NF should be used with caution in patients with known sensitivity or allergy to fish. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Adverse Reactions Allergic sensitization has been reported following both oral and parenteral administration of folic acid. UltimateCare ONE NF Dosage and Administration Usual dosage is one capsule daily, or as prescribed by a physician. How is UltimateCare ONE NF Supplied UltimateCare ONE NF prenatal/postnatal multivitamin/mineral capsules are maroon soft gelatin capsules, imprinted "TL050", packaged in bottles of 30 capsules (NDC 13811-050-30). Store at 20 -25 C (68 -77 F); excursions permitted to 15 -30 C (59 -86 F). [see USP Controlled Room Temperature]. Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436) . KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. R x Only Manufactured for: TRIGEN Laboratories, Inc. Sayreville, NJ 08872 09/11 PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label R x Only NDC 13811-050-30 30 Softgel Capsules UltimateCare ONE NF with DHA and EPA TRIGEN LABORATORIES ULTIMATECARE ONE NF omega-3 fatty acids, doconexent, icosapent, linolenic acid, calcium ascorbate, calcium threonate, cholecalciferol, .alpha.-tocopherol acetate, dl-, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, biotin, calcium, iron, ferrous asparto glycinate, iodine, magnesium oxide, zinc oxide, and docusate sodium capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-050 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 500 mg Doconexent (Doconexent) Doconexent 350 mg Icosapent (Icosapent) Icosapent 100 mg Linolenic Acid (Linolenic Acid) Linolenic Acid 50 mg Calcium Ascorbate (Calcium Ascorbate) Calcium Ascorbate 24 mg Calcium Threonate (Calcium Threonate) Calcium Threonate 1 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 800 [iU] .Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol Acetate, DL-) .Alpha.-Tocopherol Acetate, DL- 15 [iU] Riboflavin (Riboflavin) Riboflavin 1.5 mg Niacinamide (Niacinamide) Niacinamide 10 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 50 mg Folic Acid (Folic Acid) Folic Acid 1 mg Biotin (Biotin) Biotin 300 ug Calcium (Calcium Cation) Calcium 100 mg Iron (Iron) Iron 20 mg Ferrous Asparto Glycinate (Ferrous Asparto Glycinate) Ferrous Asparto Glycinate 7 mg Iodine (Iodine) Iodine 150 ug Magnesium Oxide (Magnesium Oxide) Magnesium Oxide 50 mg Zinc Oxide (Zinc Oxide) Zinc Oxide 5 mg Docusate Sodium (Docusate) Docusate Sodium 50 mg Inactive Ingredients Ingredient Name Strength Gelatin Glycerin Water Yellow Wax FD&C Red No. 40 Titanium Dioxide Ethyl Vanillin FD&C Yellow No. 6 FD&C Blue No. 1 Product Characteristics Color RED (maroon) Score no score Shape CAPSULE Size 27mm Flavor ORANGE (Creamy Orange) Imprint Code TL050 Contains Packaging # Item Code Package Description 1 NDC:13811-050-30 30 CAPSULE (CAPSULE) in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/04/2009 Labeler - TRIGEN Laboratories, Inc. (830479668) Revised: 09/2011 TRIGEN Laboratories, Inc. Next Interactions Print this page Add to My Med List More about UltimateCare One NF (multivitamin, prenatal) Side Effects Dosage Information Drug Interactions 0 Reviews Add your own review/rating Drug class: iron products Consumer resources Professional resources Other brands: Prenatal Plus , PreNexa , Prenatal 19 , Docosavit , ... +74 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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