UltimateCare ONE NF
Generic Name: prenatal vitamin supplement
Dosage Form: capsule
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.
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:
|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|
| Vitamin C Complex*
(as calcium ascorbate and calcium threonate)
|Vitamin D3 (cholecalciferol)||800 IU|
|Vitamin E (dl-alpha-tocopheryl acetate)||15 IU|
|Vitamin B2 (riboflavin, USP)||1.5 mg|
|Vitamin B3 (niacinamide)||10 mg|
|Vitamin B6 (pyridoxine hydrochloride)||50 mg|
|Folic Acid, USP||1 mg|
|Iron (elemental iron)|
|Carbonyl iron||20 mg|
|Ferrous Asparto Glycinate||7 mg|
|Magnesium (magnesium oxide)||50 mg|
|Zinc (zinc oxide, USP)||5 mg|
|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.
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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 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.
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.
Do not exceed recommended dosage. UltimateCare ONE NF should be used with caution in patients with known sensitivity or allergy to fish.
Safety and effectiveness in pediatric patients have not been established.
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.
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.
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label
30 Softgel Capsules
with DHA and EPA
|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
|Labeler - TRIGEN Laboratories, Inc. (830479668)|