Label: FOLCAPS OMEGA-3- calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopherol acetate, folic acid, pyridoxine hydrochloride, calcium, iron, ferrous asparto glycinate, doconexent, icosapent and linolenic acid capsule, gelatin coated

  • NDC Code(s): 68308-269-30
  • Packager: Midlothian Laboratories
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 01/11

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 reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    Folcaps™ Omega-3 is a prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids.

    Each red soft gelatin capsule for oral administration contains:

    *
    The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil.
    Essential Fatty Acids:
      Omega-3 Fatty Acids* (DHA, EPA, and ALA) 330 mg
        Docohexaenoic Acid (DHA) 260 mg
        Eicosapentaenoic Acid (EPA) 40 mg
        Alpha-linolenic Acid (ALA) 30 mg
      Linoleic Acid 30 mg
       
    Vitamins:
      Vitamin C (as calcium ascorbate and calcium threonate) 25 mg
      Vitamin D3 (cholecalciferol) 170 IU
      Vitamin E (dl-alpha-tocopheryl acetate) 30 IU
      Folic Acid, USP 1 mg
      Vitamin B6 (pyridoxine hydrochloride) 25 mg
       
    Minerals:
    Calcium Iron (elemental) 150 mg
      Carbonyl iron 20 mg
      Ferrous Asparto Glycinate 7 mg

    INACTIVE INGREDIENTS: Gelatin, glycerin, yellow beeswax, silicon dioxide, purified water, soy lecithin, titanium dioxide, FD&C Red #40, ethyl vanillin, and corn oil.

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  • INTENDED USE

    Folcaps™ Omega-3 is intended to provide improved nutritional status before, during, and after pregnancy, through dietary supplementation of key vitamin/mineral and omega-3 fatty acids.

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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 INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis.

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  • WARNING

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

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  • PRECAUTIONS

    General

    Do not exceed recommended dosage. Folcaps™ Omega-3 should be used with caution in patients with known sensitivity or allergy to fish or soy.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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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

    Usual dosage is one capsule daily, or as prescribed by a physician.

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  • HOW SUPPLIED

    Folcaps™ Omega-3 prenatal/postnatal multivitamin/mineral capsules are red soft gelatin, packaged in bottles of 30 capsules.
    (NDC: 68308-269-30)

    Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.]

    THIS PRODUCT CONTAINS SOY.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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  • PRINCIPAL DISPLAY PANEL - 30 Capsule Label

    NDC 68308-269-30
    30 Capsules

    Folcaps™
    Omega 3

    DESCRIPTION:
    Folcaps™ Omega-3 is a prenatal/postnatal
    multivitamin/mineral capsule with omega-3 fatty acids.

    INACTIVE INGREDIENTS: Gelatin, glycerin, yellow beeswax,
    silicon dioxide, purified water, soy lecithin, titanium dioxide,
    FD&C Red #40, ethyl vanillin, and corn oil.

    Rx Only

    Midlothian
    LABORATORIES

    PRINCIPAL DISPLAY PANEL - 30 Capsule Label
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  • INGREDIENTS AND APPEARANCE
    FOLCAPS OMEGA-3 
    calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopherol acetate, folic acid, pyridoxine hydrochloride, calcium, iron, ferrous asparto glycinate, doconexent, icosapent, and linolenic acid capsule, gelatin coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-269
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM ASCORBATE (CALCIUM ASCORBATE) CALCIUM ASCORBATE 24 mg
    CALCIUM THREONATE (CALCIUM THREONATE) CALCIUM THREONATE 1 mg
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 170 [iU]
    ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 30 [iU]
    FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
    PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
    CALCIUM (CALCIUM) CALCIUM 150 mg
    IRON (IRON) IRON 20 mg
    FERROUS ASPARTO GLYCINATE (FERROUS ASPARTO GLYCINATE) FERROUS ASPARTO GLYCINATE 7 mg
    DOCONEXENT (DOCONEXENT) DOCONEXENT 260 mg
    ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
    LINOLENIC ACID (LINOLENIC ACID) LINOLENIC ACID 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN  
    GLYCERIN  
    YELLOW WAX  
    SILICON DIOXIDE  
    WATER  
    LECITHIN, SOYBEAN  
    TITANIUM DIOXIDE  
    FD&C RED NO. 40  
    ETHYL VANILLIN  
    CORN OIL  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 25mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68308-269-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/03/2011
    Labeler - Midlothian Laboratories (142122824)
    Establishment
    Name Address ID/FEI Business Operations
    Tishcon Corporation 195342449 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Rainbow Gold Products, Inc. 800695152 REPACK
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