Label: PREFERA OB 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): 68220-089-05, 68220-089-25, 68220-089-30
  • Packager: Alaven Pharmaceutical LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated February 16, 2010

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  • SPL UNCLASSIFIED SECTION

    Prenatal/Postnatal Multivitamin/Multimineral
    PreferaOB® Tablets & life'sDHA1 Softgels

    Rx Only


    1
    life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.
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  • 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/88" 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 MINERALS
    *
    Proferrin ® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
    D3 (as cholecalciferol) 400 IU Iron
    E (as d-alpha tocopheryl succinate) 10 IU   as PIC (polysaccharide iron complex) 22 mg
    B1 (as thiamin mononitrate) 1.5 mg   as HIP (heme iron polypeptide as Proferrin®*
    B2 (as riboflavin) 1.6 mg   bovine source, USDA certified) 6 mg
    B3 (niacin as niacinamide) 17 mg Iodine (as potassium iodide) 175 mcg
    B6 (as pyridoxine HCl) 50 mg Zinc (as zinc oxide) 15 mg
    Folic Acid 1 mg Selenium (as sodium selenate) 65 mcg
    B12 (as cyanocobalamin) 12 mcg Copper (as cupric sulfate) 0.8 mg
    Biotin 30 mcg
    B5 (as d-calcium pantothenate) 10 mg

    INACTIVE INGREDIENTS

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

    Each life'sDHA™ Softgel contains:   Docosahexaenoic Acid (DHA)                      200 mg
    DHA is derived from the oils of microalgae. Inactive ingredients in the DHA softgel include: gelatin, glycerin USP, water.

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  • 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 nonlactating mothers. PreferaOB® + DHA is also beneficial in improving the nutritional status of women prior to conception.

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  • CONTRAINDICATIONS

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

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  • 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.

    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.

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  • 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.

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  • ADVERSE REACTIONS

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

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  • 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.

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  • HOW SUPPLIED

    PreferaOB® + DHA is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC 68220-089-30) and as a Professional Sample (NDC 68220-089-25).

    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]

    Dispense in a tight, light-resistant container to protect from light and moisture.

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  • SPL UNCLASSIFIED SECTION

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

    www.PreferaOB.com

    Manufactured for:
    Alaven® Pharmaceutical LLC, Marietta, GA 30062

    Patents Pending

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

    089-0709-01
    Ref CL-089-0709-01

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  • PRINCIPAL DISPLAY PANEL - 30 Tablets + 30 Softgels Carton

    Rx Only

    NDC 68220-089-30
    30 Tablets + 30 Softgels

    PreferaOB®
    + DHA

    The Prenatel YOU CAN COUNT ON!

    ONLY prenatal with Natural, Body-Ready HEME Iron + DHA

    15 Essential Vitamins and Minerals including:

    Plant-based life'sDHA™ Omega-3
    High dose of vitamin B 6
    1mg of folic acid

    ACTUAL
    SIZE

    Pre/Post-natal Nutritional
    Supplement + DHA

    www.PreferaOB.com

    PRINCIPAL DISPLAY PANEL - 30 Tablets + 30 Softgels Carton
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  • INGREDIENTS AND APPEARANCE
    PREFERA OB 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 Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-089
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    Heme Iron Polypeptide (UNII: 31VDO12CJY) (Heme Iron Polypeptide - UNII:31VDO12CJY) Heme Iron Polypeptide 6 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (IRON DEXTRAN - UNII:95HR524N2M) IRON DEXTRAN 22 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodine - UNII:9679TC07X4) Potassium Iodide 175 ug
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc - UNII:J41CSQ7QDS) Zinc Oxide 15 mg
    Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium 65 ug
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (COPPER - UNII:789U1901C5) CUPRIC SULFATE 0.8 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE 1.5 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) RIBOFLAVIN 1.6 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 17 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 30 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (CALCIUM PANTOTHENATE - UNII:568ET80C3D) CALCIUM PANTOTHENATE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    ETHYLCELLULOSE (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
    Color PURPLE Score 2 pieces
    Shape OVAL Size 15mm
    Flavor Imprint Code AP;88
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68220-089-05 5 in 1 BLISTER PACK
    2 NDC:68220-089-30 30 in 1 CARTON
    3 NDC:68220-089-05 5 in 1 BLISTER PACK
    4 NDC:68220-089-25 5 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/01/2009
    Labeler - Alaven Pharmaceutical LLC (140210829)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma Inc. 160356114 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Carton Services Inc 004215968 REPACK
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