Label: PREFERAOB PLUS DHA- folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, selenium, cupric sulfate, cholecalciferol, thiamine mononitrate, alpha-tocopherol succinate, d-, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, and calcium pantothenate tablet

  • NDC Code(s): 68220-083-05, 68220-083-30
  • Packager: Alaven Pharmaceutical LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 January 18, 2011

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

  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    PreferaOB + DHA™ is a prescription prenatal/postnatal multivitamin/multimineral (PreferaOB®) and Omega-3 fatty acid (life'sDHA™) nutritional supplement. PreferaOB + DHA™ is: a small, oval, film-coated, purple tablet with black core, debossed and bisected with "AP/84" on one side, and plain on the other (PreferaOB®) and a clear essential fatty acid softgel containing an amber to light/dark orange semi-solid mixture (life'sDHA™).

    Each PreferaOB® tablet contains:
    VITAMINS
    D3 (as cholecalciferol)400 IU
    E (as d-alpha tocopheryl succinate)10 IU
    B1 (as thiamin mononitrate)1.5 mg
    B2 (as riboflavin)1.6 mg
    B3 (niacin as niacinamide)17 mg
    B6 (as pyridoxine HCl)50 mg
    Folic Acid1 mg
    B12 (as cyanocobalamin)12 mcg
    Biotin30 mcg
    B5 (as d-calcium pantothenate)10 mg
    MINERALS
    Iron
      as Polysaccharide Iron Complex (a complex of iron, glucose,   maltose, and dextrin; Iron Content ~ 46%) yielding28 mg
      as HIP (heme iron polypeptide as Proferrin®** -
      bovine source, USDA certified) yielding
    6 mg
    Iodine (as potassium iodide)250 mcg
    Zinc (as zinc oxide)4.5 mg
    Selenium (as sodium selenate)65 mcg
    Copper (as cupric sulfate)0.8 mg

    INACTIVE INGREDIENTS:

    Microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate (vegetable source), silicon dioxide, dextran, dicalcium phosphate, protease, modified food starch, sucrose, dl-alpha tocopherol, sodium ascorbate, ethylcellulose, resin, coating (polydextrose, hypermellose, titanium dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake, polyethylene glycol, hydroxypropyl cellulose, purified water).

    Each life'sDHA™ Softgel contains:
    Total omega-3 long chain fatty acids203 mg
      as Docosahexaenoic Acid (DHA)200 mg
      as α-linolenic acid (ALA)0.5 mg
      as Docosapentaenoic acid (DPA)2.5 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. Ingredients include: DHA Algal Oil, High Oleic Sunflower Oil, Ascorbyl Palmitate & Tocopherols (as antioxidants) in a Gelatin Capsule (Gelatin, Glycerin, Water, and Caramel, Carmine, Calcium Carbonate and Turmeric as coloring).

  • INDICATIONS AND USAGE

    PreferaOB + DHA™ is a prescription multivitamin/multimineral (PreferaOB®) and Omega-3 fatty acid (life'sDHA™) nutritional supplement 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 + DHA™ 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 0.1mg 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 tablet and one softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

  • HOW SUPPLIED

    PreferaOB + DHA™ is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC 68220-083-30) and as a Professional Sample (NDC 68220-083-25).

    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.

  • SPL UNCLASSIFIED SECTION

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

    www.PreferaOB.com

    life'sDHA
    HEALTHY BRAIN, EYES, HEART

    Manufactured for:
    ALAVEN®
    PHARMACEUTICAL LLC

    Alaven® Pharmaceutical LLC, Marietta, GA 30062

    U.S. Patent No. 7,585,527
    *life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.
    **Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
    PreferaOB® is a registered trademark and PreferaOB + DHA™ is a
    trademark of Alaven® Pharmaceutical LLC, Marietta, GA.

    6-083-30-06-0710CR

    Ref CL6-083-00-01-0710b

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Carton

    Rx Only

    NDC 68220-083-30
    30 Tablets + 30 Softgels

    PreferaOB
    +DHA

    life'sDHA
    HEALTHY BRAIN, EYES, HEART

    ONLY prenatal with Natural,
    Body-Ready HEME Iron + DHA
    15 Essential Vitamins and
    Minerals including:

    -
    50mg of vitamin B6
    -
    1mg of folic acid

    Plus Plant-based life'sDHA™ Omega-3

    Pre/Post-natal Nutritional
    Supplement + DHA

    www.PreferaOB.com

    PRINCIPAL DISPLAY PANEL - 30 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    PREFERAOB PLUS DHA 
    folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, selenium, cupric sulfate, cholecalciferol, thiamine mononitrate, alpha-tocopherol succinate, d-, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, and calcium pantothenate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68220-083
    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 DEXTRAN28 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodine - UNII:9679TC07X4) Potassium Iodide250 ug
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc - UNII:J41CSQ7QDS) Zinc Oxide4.5 ug
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium65 ug
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (COPPER - UNII:789U1901C5) CUPRIC SULFATE0.8 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE1.5 mg
    ALPHA-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (ALPHA-TOCOPHEROL SUCCINATE, D- - UNII:LU4B53JYVE) ALPHA-TOCOPHEROL SUCCINATE, D-10 [iU]
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.6 mg
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 66 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 51.5 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 5 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5 mg
    DEXTRAN 1 (UNII: I8LHQ0D645)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SUCROSE (UNII: C151H8M554)  
    ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE (UNII: Z3GVO2327F)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code AP;84
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68220-083-055 in 1 BLISTER PACK
    2NDC:68220-083-3030 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER11/15/2010
    Labeler - Alaven Pharmaceutical LLC (140210829)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma Inc.160356114MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Carton Services Inc004215968REPACK