Label: OB COMPLETE PREMIER- .beta.-carotene, calcium ascorbate, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron, ferrous asparto glycinate, magnesium malate, zinc glycinate, and copper tablet, coated

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated February 18, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SUPPLEMENT FACTS

    OBComplete Premier Supplement Facts box

    Other Ingredients: Microcrystalline Cellulose, DiCal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc and FDC Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Acacia and Povidone K30.


    VEGETARIAN FRIENDLY


    GLUTEN-, LACTOSE- AND SUGAR-FREE


    OB Complete® Premier 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® Premier should not be used by patients with a known hypersensitivity to any of the listed ingredients.

  • WARNINGS

     WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP 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® Premier tablets 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® Premier is pink tablet, imprinted "VP043".

  • DIRECTIONS FOR USE

    One tablet daily or as directed by a physician.

  • HOW SUPPLIED

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


    Product Code: 68025-043-30

  • 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 and TRAACS are registered trademarks of Albion International, Inc. Malates covered by U.S. Patent No. 6,706,904. Chelate covered by U.S. Patent No. 7,838,042 and patents pending.


    **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 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

     
    PLR-OBCPR-00005-2     Rev. 02/2022


    Distributed by:
    Vertical Pharmaceuticals, LLC
    Alpharetta, GA 30005

    logo

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

    68025-043-30

    Vegetarian Friendly,
    Gluten, Lactose and
    Sugar-Free

    OB
    COMPLETE
    ®
    Premier

    30 Tablets

    VERTICAL
    PHARMACEUTICALS, LLC

    OB Complete Premier Trade Carton Rev. 02/2022
  • INGREDIENTS AND APPEARANCE
    OB COMPLETE PREMIER 
    .beta.-carotene, calcium ascorbate, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium malate, iron, ferrous asparto glycinate, magnesium malate, zinc glycinate, and copper tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE2100 [iU]
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-20 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
    CALCIUM MALATE (UNII: D48OP746DW) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION100 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
    MAGNESIUM MALATE (UNII: LA9X9UJA2Z) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION15 mg
    ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
    CUPRIC GLYCINATE (UNII: 68VAV8QID7) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ACACIA (UNII: 5C5403N26O)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68025-043-303 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
    imprint
    scoring1
    shape
    size (solid drugs)19 mm
    Labeler - Vertical Pharmaceuticals, LLC (173169017)