UltimateCare ONE NF

prenatal vitamin supplement

Dosage Form: capsule
UltimateCare ONE NF

A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid.

Rx Only

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 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.

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.

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.

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

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 13811-050-30 30 CAPSULE In 1 BOTTLE None

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: 09/2011TRIGEN Laboratories, Inc.

More UltimateCare ONE NF resources

• UltimateCare ONE NF Side Effects (in more detail)
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• UltimateCare ONE NF Drug Interactions
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