Medication Guide App

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.

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 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.
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