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 kit

  • 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 October 17, 2019

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

  • SPL UNCLASSIFIED SECTION

    0642-0075-30

    Prenatal Supplement with DHA

    Rx

  • COMPOSITION

    *
    (providing 250mg DHA (docosahexaenoic acid)
    Each SELECT-OB® caplet contains:
    Vitamin A (as acetate & beta carotene)1700 IU
    Vitamin C (as ascorbic acid)60 mg
    Vitamin D3 (as cholecalciferol)400 IU
    Vitamin E (as dl-alpha tocopheryl acetate)30 IU
    Thiamine mononitrate (Vitamin B1)1.6 mg
    Riboflavin (Vitamin B2)1.8 mg
    Niacin (as niacinamide)15 mg
    Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
    Folic acid1 mg
    Vitamin B12 (as cyanocobalamin)5 mcg
    Iron (as polysaccharide iron complex)29 mg
    Magnesium (as magnesium oxide)25 mg
    Zinc (as zinc oxide)15 mg
    Each DHA softgel capsule contains:
    Algal oil blend (derived from Natural Algal Oil)
    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.

  • 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.

  • CONTRAINDICATIONS

    SELECT-OB®+DHA is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

    Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitaminB12).

  • 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 a Poison Control Center immediately.

  • WARNINGS/PRECAUTIONS

    SELECT OB®+DHA should be used with caution in patients with known sensitivity or allergy to soy.

    Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased rick of heart disease can occur. Prolonged use of iron slats may produce iron storage disease.

    Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.

    Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.

    Avoid overdosage. Keep out of the reach of children.

    Drug Interactions

    High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.

    Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

    Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions.

    Information for Patients

    Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

    Pediatric Use

    Not for pediatric use.

  • ADVERSE REACTIONS

    Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in SELECT OB®+DHA.

  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Rx

    Distributed by:
    Exeltis USA, Inc.
    Florham Park, NJ 07932

    1-877-324-9349
    www.exeltisusa.com
    ©2018 Exeltis USA, Inc.

    U.S. Patent No. 7,560,123; 8,101,587; 8,197,855; and 8,609,629
    Select -OB® is a trademark of Exeltis USA, Inc.

    Rev. November 2018

    0753001-01

  • 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 natural source DHA

    New
    Smaller DHA Softgel

    DOES NOT CONTAIN
    FISH OIL

    RX
    Unit Dose Pack
    30 Caplets and 30 Softgel Capsules
    U.S. Patented

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0075
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0075-301 in 1 CARTON04/08/2009
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOX 30 
    Part 21 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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE600 [iU]
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A1100 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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) Thiamine1.6 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) NIACINAMIDE15 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.4 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM0.6 mg
    Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin5 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    FRUCTOSE (UNII: 6YSS42VSEV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALIC ACID (UNII: 817L1N4CKP)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize19mm
    FlavorBERRY (Mixed Berry) Imprint Code EV0077
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/08/2009
    Part 2 of 2
    DHA 
    doconexant capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (Amber) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/08/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/08/2009
    Labeler - Exeltis USA, Inc. (071170534)