Label: SELECT-OB PLUS DHA PRENATAL SUPPLEMENT PLUS DHA- .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, zinc oxide, and doconexant

  • 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 August 9, 2017

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

  • 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 the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

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  • DESCRIPTION

    Prenatal Supplement with DHA

    Supplement Facts
    Serving Size 1 Caplet and 1 Softgel Capsule
    Each Caplet contains % Daily Value in Pregnancy
    *
    (providing 250mg DHA (docosahexaenoic acid))
    Daily Value not established
    Vitamin A (as acetate and beta carotene) 1700 IU  21%
    Vitamin C (as ascorbic acid) 60 mg 100%
    Vitamin D3 (as cholecalciferol) 400 IU  100%
    Vitamin E (as dl-alpha tocopheryl acetate) 30 IU  100%
    Thiamine Mononitrate (Vitamin B1) 1.6 mg 94%
    Riboflavin (Vitamin B2) 1.8 mg 90%
    Niacin (as niacinamide) 15 mg 75%
    Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg 100%
    Folic acid 1 mg 125%
    Vitamin B12 (as cyanocobalamin)  5 mcg 63%
    Elemental Iron (as polysaccharide iron complex) 29 mg 161%
    Magnesium (as magnesium oxide) 25 mg 6%
    Zinc (as zinc oxide) 15 mg 100%
    Each Softgel Capsule contains
    Algal oil blend
      (derived from crypthecodinium cohnii)
    486 mg*

    Other Ingredients in Select-OB® Caplet: Fructose, Stearic Acid, Mono and Diglycerides, Croscarmellose Sodium, Mixed Berry Flavor WONF, Gelatin (Porcine), Silicon Dioxide, Citric Acid, Magnesium Stearate, Modified Food Starch, Hydroxypropylmethyl Cellulose, Malic Acid, Sucrose, Corn Starch, Dicalcium Phosphate, Sodium Ascorbate, Medium Chain Triglycerides, Sorbic Acid, Tocopherol Concentrate, Sodium Benzoate, dl-Alpha-Tocopherol, Butylated Hydroxytoluene (BHT), Tricalcium Phosphate. Coating: Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polydextrose, Hydroxypropyl Cellulose, Triacetin, Polyethylene Glycol, FD&C Blue #1 / Aluminum Lake, FD&C Blue #2 / Aluminum Lake. Contains: Soy.

    Other Ingredients in DHA Softgel Capsule: Gelatin, Glycerin USP, Water.

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  • INDICATIONS AND USAGE

    Select-OB®+DHA is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Select-OB®+DHA does not contain fish, fish oils, fish proteins or fish byproducts.

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  • DOSAGE AND ADMINISTRATION

    Before, during and after pregnancy, chew or swallow one blue Select-OB® caplet and swallow one DHA softgel capsule daily, or as directed by a physician.

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  • HOW SUPPLIED

    Select-OB®+DHA is available as a light blue caplet debossed EV0077 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 Select-OB® caplets and 5 DHA softgel capsules each), (0642-0075-30) and as professional samples (0642-0075-03).

    Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

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  • SPL UNCLASSIFIED SECTION

    Rx

    See package insert for full prescribing information

    Manufactured for
    EVERETT LABORATORIES, INC. Chatham, NJ 07928
    1-877-324-9349

    U.S. Patent No. 7,560,123; 8,101,587; 8,197,855 and 8,609,629
    Select-OB® is a trademark of Everett Laboratories, Inc.
    life'sDHA is a trademark of DSM.
    U.S. Patent No. 7,163,811and 7,824,892
    (Rev. 03/14)

    (Rev. 03/14)

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    0642-0075-30

    Select-OB®+DHA

    Prenatal Supplement with DHA

    Berry flavored BLUE Select-OB® Caplet
    can be chewed or swallowed

    DHA Softgel Capsule
    from plant source DHA

    New
    Smaller DHA Softgel

    DOES NOT CONTAIN
    FISH OIL

    life's DHA
    HEALTHY BRAIN, EYES, HEART

    Unit Dose Pack
    30 Caplets and 30 Softgel Capsules

    Rx

    U.S. PATENTED

    PRINCIPAL DISPLAY PANEL -  Kit Carton
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  • INGREDIENTS AND APPEARANCE
    SELECT-OB PLUS DHA  PRENATAL SUPPLEMENT PLUS DHA
    .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, zinc oxide, and doconexant kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0075
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0642-0075-30 1 in 1 CARTON 04/08/2009
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOX 30 
    Part 2 1 BOX 30 
    Part 1 of 2
    SELECT-OB 
    .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, and zinc oxide tablet, coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.Beta.-Carotene - UNII:01YAE03M7J) .BETA.-CAROTENE 600 [iU]
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A 1100 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.6 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.8 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) NIACINAMIDE 15 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.4 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 0.6 mg
    Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin 5 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 29 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) MAGNESIUM OXIDE 25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) ZINC OXIDE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    FRUCTOSE (UNII: 6YSS42VSEV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
    Berry (UNII: FV3431923Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Gelatin (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Sorbic Acid (UNII: X045WJ989B)  
    Tocopherol (UNII: R0ZB2556P8)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Tricalcium Phosphate (UNII: K4C08XP666)  
    Polydextrose (UNII: VH2XOU12IE)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 19mm
    Flavor BERRY (Mixed Berry) Imprint Code EV0077
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 04/08/2009
    Part 2 of 2
    DHA 
    doconexant capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color YELLOW (Amber) Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 04/08/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 04/08/2009
    Labeler - Exeltis USA, Inc. (071170534)
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