UltimateCare
UltimateCare ONE NF
FULL PRESCRIBING INFORMATION: CONTENTS*
- ULTIMATECARE DESCRIPTION
- INDICATIONS
- ULTIMATECARE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ULTIMATECARE ADVERSE REACTIONS
- ULTIMATECARE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label
FULL PRESCRIBING INFORMATION
A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid.
Rx Only
ULTIMATECARE 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 |
| Vitamins: | |
| Vitamin C Complex
(as calcium ascorbate and calcium threonate) |
25 mg |
| 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 |
| 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.
ULTIMATECARE 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 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.
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.
ULTIMATECARE ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
ULTIMATECARE DOSAGE AND ADMINISTRATION
Usual dosage is one capsule daily, or as prescribed by a physician.
HOW 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.
Rx Only
Manufactured for:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
09/11
PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label
Rx Only
NDC 13811-050-30
30 Softgel Capsules
UltimateCare
ONE NF
with DHA and EPA
TRIGEN
LABORATORIES
UltimateCareOmega-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
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