Label: OB COMPLETE DHA- omega-3 fatty acids, calcium ascorbate, calcium threonate, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, ferrous asparto glycinate, zinc oxide, and cupric sulfate capsule, liquid filled

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 7, 2020

If you are a consumer or patient please visit this version.

  • SUPPLEMENT FACTS

    OB CompleteDHASF

    Other Ingredients: Soybean Oil, Gelatin, Glycerin, Yellow Bees Wax, Lecithin, Purified Water, Carmine Hydrosoluble, Titanium Dioxide, Ethyl Vanillin, FD&C Red #40, FD&C Blue #1

    THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVIES, MACKEREL, SARDINES, TUNA).

    GLUTEN-, LACTOSE- AND SUGAR-FREE

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

     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.

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

  • DRUG INTERACTIONS

    OB Complete® with DHA Prenatal Multivitamin/Multimineral is 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® with DHA is a purple, oval shaped softgel capsule imprinted with “VP049”.

  • DIRECTIONS FOR USE

    Take one softgel capsule by mouth daily or as directed by a physician.

  • HOW SUPPLIED

    OB Complete® with DHA Prenatal Multivitamin/Multimineral softgels are available in 60 count bottles.

    Product Code: 68025-049-60

  • 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.

    ***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 1-877-482-3788 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Customer Service: 1-866-600-4799                                                                  Rev. 01/2020

    Distributed by:
    Vertical Pharmaceuticals, LLC
    Bridgewater, NJ 08807
    www.verticalpharma.com

    verticallogo

  • PRINCIPAL DISPLAY PANEL - 60 Softgel Bottle Label

    OB
    Complete®

    with DHA
    Prenatal
    Multivitamin

    68025-049-60
    60 Softgels

    OB Complete with DHA Bottle Label Rev. 012020
  • INGREDIENTS AND APPEARANCE
    OB COMPLETE DHA 
    omega-3 fatty acids, calcium ascorbate, calcium threonate, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, ferrous asparto glycinate, zinc oxide, and cupric sulfate capsule, liquid filled
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-049
    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 Acids200 mg
    Calcium Ascorbate (UNII: 183E4W213W) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid120 mg
    Calcium Threonate (UNII: HBB4YPO93U) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Threonate5 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol1000 [iU]
    .Alpha.-Tocopherol, D- (UNII: N9PR3490H9) (.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) Riboflavin3.4 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) Cyanocobalamin15 ug
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
    Ferrous Asparto Glycinate (UNII: H7426RGB3L) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation10 mg
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
    Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Cation1 mg
    Inactive Ingredients
    Ingredient NameStrength
    Soybean Oil (UNII: 241ATL177A)  
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Water (UNII: 059QF0KO0R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    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:68025-049-6060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/01/2011
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)15 mm
    Labeler - Vertical Pharmaceuticals, LLC (173169017)