UltimateCare ONE Prenatal

UltimateCare ONE by

Drug Labeling and Warnings

UltimateCare ONE by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTIMATECARE ONE- omega-3 fatty acids, linoleic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, calcium carbonate, iron, and ferrous asparto glycinate capsule 
Trigen Laboratories, LLC

----------

UltimateCare ONE
Prenatal

Rx Only

DESCRIPTION

UltimateCare ONE is a prescription prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each maroon softgel capsule is imprinted with "TL049."

Supplement Facts
Servings per Bottle: 30
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains
DV% for Pregnant and Lactating Women
  • * Daily value not established.
  • Vitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.
  • Sumalate™ (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah.
  • Omega-3 Fatty Acids330 mg*  
      Docosahexaenoic Acid (DHA)260 mg*  
      Eicosapentaenoic Acid (EPA)  40 mg*  
      a-Linoleic Acid (ALA)  30 mg*  
    Linoleic Acid  30 mg*  
    Vitamin C Complex  25 mg42%
    Vitamin D3 (cholecalciferol)170 IU43%
    Vitamin E (dl-alpha-tocopheryl acetate)  30 IU100%
    Folic Acid, USP    1 mg125%
    Vitamin B6 (pyridoxine HCl)  25 mg1000%
    Calcium (calcium carbonate)150 mg12%
    Iron
      Carbonyl iron (elemental iron)  20 mg111%
      Sumalate™ (elemental iron)    7 mg39%

    Inactive Ingredients

    Gelatin, Glycerin, Lecithin, Purified Water, Natural Creamy Orange Flavor, Carmine, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1.

    INDICATIONS

    UltimateCare ONE 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 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 1.0 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

    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 functions, and of concomitant disease or other drug therapy.

    ADVERSE REACTION

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    DOSAGE AND ADMINISTRATION

    Usual dosage is one capsule daily, or as prescribed by a physician.

    HOW SUPPLIED

    UltimateCare ONE is Supplied in bottles of 30 capsules.

    PRODUCT CODE 13811-049-30

    STORAGE

    Store at 20° -25°C (68° -77°F), excursions permitted to 15° -30°C (59° -86°F) [See USP controlled room temperature].

    Protect from moisture and excessive heat.

    Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

    KEEP OUT OF THE REACH OF CHILDREN.

    Rx Only

    All prescriptions using this product shall be pursuant to statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

    Manufactured for:
    TRIGEN Laboratories, Inc., Sayreville, NJ 08872
    www.trigenlab.com

    Rev. 02/13

    PRINCIPAL DISPLAY PANEL - 30 Softgel Capsule Bottle Label

    13811-049-30
    Rx Only

    UltimateCare
    ONE

    Prenatal with DHA & EPA

    30 Softgel Capsules

    TRIGEN
    LABORATORIES

    Principal Display Panel - 30 Softgel Capsule Bottle Label
    ULTIMATECARE ONE 
    omega-3 fatty acids, linoleic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, calcium carbonate, iron, and ferrous asparto glycinate capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids330 mg
    Linoleic Acid (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) Linoleic Acid30 mg
    Ascorbic Acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) Ascorbic Acid25 mg
    Cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) Cholecalciferol170 [iU]
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
    Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) Folic Acid1 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
    Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Carbonate150 mg
    Iron (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) Iron20 mg
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION7 mg
    Inactive Ingredients
    Ingredient NameStrength
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    Pigment Red 48 (UNII: 07XHK4SAV6)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-049-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/01/201012/31/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)25 mm
    Labeler - Trigen Laboratories, LLC (830479668)

    Revised: 11/2019