OB COMPLETE PETITE (CALCIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON, FERROUS A

OB COMPLETE PETITE (CALCIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON, FERROUS A
PDF | XML

NDC 68025-059-30
Set ID 6bffb66f-6b1b-44e2-ba4d-211091e99ef7
Category DIETARY SUPPLEMENT
Packager Vertical Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number
  • SUPPLEMENT FACTS

    Supplement Facts box

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

    CONTAINS: SOY AND FISH OIL (ANCHOVY)

     

    GLUTEN-, LACTOSE-, AND SUGAR-FREE

    OB Complete® Petite 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

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • 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.

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

  • DRUG INTERACTIONS

    OB Complete®Petite softgel capsules 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® Petite is an oval-shaped plum colored softgel capsule, imprinted "VP 059".

  • DIRECTIONS FOR USE

    One softgel capsule daily or as directed by a physician.

  • HOW SUPPLIED

    OB Complete® Petite is supplied in a 30 count child-resistant bottle.

    Product Code: 68025-059-30

  • STORAGE

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

  • HEALTH CLAIM

    KEEP OUT OF REACH OF CHILDREN.

     

    PATENTED FORMULA.  U.S. PAT. No. 8,263,137

    **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. 06/2018

    Distributed by:

    Vertical Pharmaceuticals, LLC

    Bridgewater, NJ 08807

    vERTICAL LOGO

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    68025-059-30

    OB
    COMPLETE
    ®

    Petite

    Gluten,
    Lactose and
    Sugar-Free

    VERTICAL
    PHARMACEUTICALS, LLC

    30 SOFTGEL
    CAPSULES

     

    Label1

    Label3Label 2

  • INGREDIENTS AND APPEARANCE
    OB COMPLETE PETITE 
    calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, ferrous asparto glycinate, zinc oxide, cupric sulfate, and doconexent capsule, liquid filled
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-059
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID75 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [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) 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 (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON35 mg
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION5 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    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:68025-059-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/26/2012
    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)