Label: PREFERAOB ONE- folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin and calcium pantothenate capsule capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 8, 2010

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

  • SPL UNCLASSIFIED SECTION

    Prenatal/Postnatal Multivitamin/
    Multimineral/DHA softgel

    Rx Only

  • DESCRIPTION

    PreferaOB ONE is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA1). PreferaOB ONE is an oblong shaped, opaque purple colored softgel, imprinted "AP 86" in white ink on one side and plain on the other.

    Each PreferaOB ONE Softgel contains:

    *
    Proferrin® is a registered trademark of Colorado Biolabs, Inc , Cozad, NE.
    Vitamin C (as ascorbic acid)25 mg
    Vitamin D3 (as cholecalciferol)400 IU
    Vitamin E (as dl-alpha tocopheryl acetate)10 IU
    Vitamin B3 (niacin as niacinamide)17 mg
    Vitamin B6 (as pyridoxine HCl)50 mg
    Folic Acid1 mg
    Vitamin B12 (as cyanocobalamin)12 mcg
    Biotin30 mcg
    Vitamin B5 (as d-calcium pantothenate)10 mg
    Iron
     as PIC (polysaccharide iron complex)22 mg
     as HIP (heme iron polypeptide as
     Proferrin®* -bovine source, USDA certified)6 mg
    Iodine (as potassium iodide)175 mcg
    Zinc (as zinc oxide)15 mg
      
    Docosahexaenoic Acid (DHA)200 mg

    DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination.

    Inactive Ingredients

    Gelatin, soybean oil, yellow beeswax, and lecithin.


    1
    life'sDHA is a trademark of Martek Biosciences Corporation, Columbia, MD.
  • INDICATIONS AND USAGE

    PreferaOB ONE is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™) indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreferaOB ONE is also beneficial in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS

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

  • WARNING

    Ingestion of more than 3 grams of Omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of Omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis.

  • BOXED WARNING (What is this?)

    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 when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

  • ADVERSE REACTIONS

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

  • DOSAGE AND ADMINISTRATION

    One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

  • HOW SUPPLIED

    PreferaOB ONE is supplied in child-resistant blister packs of 30 softgels (NDC 68220-086-30) and as a Professional Sample (NDC 68220-086-25).

    KEEP OUT OF REACH OF CHILDREN.

    STORAGE

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

    To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.

    For medical inquiries call toll free
    1-888-317-0001

    www.PreferaOB.com

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Alaven® Pharmaceutical LLC
    Marietta, GA 30062

    U.S. Patent No. 7,585,527

    PreferaOB® is a registered trademark and PreferaOB ONE is a trademark of Alaven® Pharmaceutical LLC, Marietta, GA.

    CL6-086-00-01-1209a

  • PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Package

    Rx Only
    NDC 68220-086-30

    30 Softgels

    PreferaOB ONE

    The Prenatal YOU CAN COUNT ON!

    FIRST and ONLY prenatal with Natural,
    Body-Ready HEME Iron + DHA In
    an all-in-one softgel

    12 Essential Vitamins
    and Minerals including:

    - High dose of vitamin B6

    - 1mg of folic acid

    Plus Plant-based life'sDHA™ Omega-3

    Pre/Post-natal Nutritional

    Supplement + DHA

    life'sDHA™

    www.PreferaOB.com

    Chemical Structure
  • INGREDIENTS AND APPEARANCE
    PREFERAOB ONE 
    folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin and calcium pantothenate capsule capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68220-086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    Heme Iron Polypeptide (UNII: 31VDO12CJY) (Heme Iron Polypeptide - UNII:31VDO12CJY) Heme Iron Polypeptide6 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (IRON DEXTRAN - UNII:95HR524N2M) IRON DEXTRAN22 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (Potassium Cation - UNII:295O53K152) Potassium Iodide175 ug
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide15 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid25 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT200 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL ACETATE, DL- - UNII:WR1WPI7EW8) .ALPHA.-TOCOPHEROL ACETATE, DL-10 [iU]
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE17 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (CALCIUM PANTOTHENATE - UNII:568ET80C3D) CALCIUM PANTOTHENATE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) 58 mg
    WAX, YELLOW (UNII: 2ZA36H0S2V) 34 mg
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 10 mg
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code AP;86
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68220-086-306 in 1 CARTON
    1NDC:68220-086-055 in 1 BLISTER PACK
    2NDC:68220-086-251 in 1 CARTON
    2NDC:68220-086-055 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/01/2010
    Labeler - Alaven Pharmaceutical LLC (140210829)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Vitamin Corporation961594343MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Carton Services Inc004215968REPACK