OB COMPLETE ONE (FISH OIL, DOCONEXENT, ICOSAPENT, CALCIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE,

OB COMPLETE ONE (FISH OIL, DOCONEXENT, ICOSAPENT, CALCIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE,
PDF | XML

NDC 68025-044-30
Set ID 39bd64e4-e330-4a3f-b873-3d71b07e54aa
Category DIETARY SUPPLEMENT
Packager Vertical Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number
  • SUPPLEMENT FACTS

    SF

    Other Ingredients: Gelatin, Glycerin, Yellow Bees Wax, Purified Water, Lecithin (Soybean Oil), Natural Cream Orange Flavor, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1.

     

    CONTAINS: SOY AND FISH (TUNA)

    GLUTEN-, LACTOSE- AND SUGAR-FREE

     

    OB Complete® One is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.

  • CONTRAINDICATIONS

    OB Complete® One should not be used by patients with a known hypersensitivity to any of the listed ingredients including soy and fish oil.

  • WARNINGS

     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.
  • PRECAUTIONS

    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 neurologic manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.


    Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.


    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

  • DRUG INTERACTIONS

    OB Complete® One softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.  There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

  • ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

  • DESCRIPTION

    OB Complete® One is an oblong-shaped purple softgel, imprinted "VP044".

  • DIRECTIONS FOR USE

    One softgel by mouth daily or as directed by a physician.

  • HOW SUPPLIED

    OB Complete® One is supplied in a carton of 30 capsules, packaged in 3 child resistant unit-dose blister cards of 10 softgels per card.

    Product Code: 68025-044-30

  • STORAGE

    Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light, moisture and excessive heat.

  • HEALTH CLAIM

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

    *DimaCal is a registered trademark of Albion International, Inc.

    Malates covered by U.S. Patent No. 6,706,904.

    **Sumalate® (Ferrous Asparto Glycinate) is a registered trademark of Albion International, Inc. and is covered by the following patents: U.S. Pat. No. 6,716,814; U.S. Pat. No. 8,007,846 and U.S. Pat. No. 8,425,956.

    For use on the order of a healthcare practitioner.


    Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-877-95-VERTI (1-877-958-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

     

    Customer Service: 1-866-600-4799                                   Rev. 09/2018  

     

    Distributed by:

    Vertical Pharmaceuticals, LLC

    Bridgewater, NJ 08807

    VERTICAL LOGO

  • PRINCIPAL DISPLAY PANEL

    68025-044-30

    OB
    COMPLETE
    ®
    One

    Gluten,
    Lactose and
    Sugar-Free

    VERTICAL
    PHARMACEUTICALS, LLC

    30 Softgels

    Carton
  • INGREDIENTS AND APPEARANCE
    OB COMPLETE ONE 
    fish oil, doconexent, icosapent, calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium threonate, calcium malate, calcium carbonate, iron, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide, and cupric sulfate capsule, liquid filled
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F) FISH OIL476 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT40 mg
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID70 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1200 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE30 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN50 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN200 ug
    CALCIUM THREONATE (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM THREONATE5 mg
    CALCIUM MALATE (UNII: D48OP746DW) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION25 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION25 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON40 mg
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION10 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68025-044-303 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/31/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)23 mm
    Labeler - Vertical Pharmaceuticals, LLC (173169017)