Label: C-NATE DHA- omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide capsule, gelatin coated

  • NDC Code(s): 23359-105-01, 23359-105-05, 23359-105-30
  • Packager: Centurion Labs, 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 16, 2014

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

  • SPL UNCLASSIFIED SECTION

    PRENATAL / MULTIVITAMIN

    Rev. 10/12

    Rx ONLY

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  • Description:
  • DESCRIPTION

    Each Softgel Contains:
    Omega-3 Fatty Acids (DHA-EPA) 200mg
    Vitamin B1 (Thiamine Mononitrate) 3 mg
    Vitamin B2 (Riboflavin) 3 mg
    Vitamin B6 (Pyridoxine HCL) 20 mg
    Vitamin B12 (Cyanocobalamin) 15 mcg
    Folic Acid 1 mg
    Vitamin D3 (Cholecalciferol) 400 IU
    Vitamin C (Ascorbic Acid) 100 mg
    Vitamin E (d-alpha tocopherol) 30 IU
    Copper (Cupric Sulfate) 1 mg
    Zinc (Zinc Oxide) 20 mg
    Iron (Fumerate) 28 mg
    Magnesium 30 mg
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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Gelatin, Glycerol, beeswax yellow, lecithin, water-purified and colorant.

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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS: C-NATE DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients.

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  • PRECAUTIONS

    PRECAUTIONS: 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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  • WARNINGS

    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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  • PEDIATRIC USE

    PEDIATRIC USE: Safety and effectiveness in pediactric patients has not been established.

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  • GERIATRIC USE

    GERIACTRIC USE: No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly person may have decreased hepatic, renal, or cardiac function.

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  • DRUG INTERACTIONS

    DRUG INTERACTIONS: C-NATE DHA softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Usual adult dose: one softgel daily or as prescribed by your doctor.

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  • HOW SUPPLIED

    HOW SUPPLIED: C-NATE DHA is available as a Annato colored softgel, imprinted PRE 01. Available in 30 count bottles with NDC #23359-105-30 and samples with NDC #23359-105-05 and NDC #23359-105-01.

    PHYSICIAN SAMPLE NOT FOR RESALE

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  • STORAGE AND HANDLING

    Recommended Storage: 15°-30°C (59°-86°F) degrees. Protect from light moisture and avoid excessive heat. Dispense original carton.

    KEEP OUT OF REACH OF CHILDREN

    RX ONLY

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  • SPL UNCLASSIFIED SECTION

    CENTURION LABS, LLC
    BIRMINGHAM, AL 35243

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 23359-105-30

    C-Nate
    DHA

    Softgels
    Omega-3 Fatty Acids (DHA-EPA) 200mg
    Vitamin B1 (Thiamine Mononitrate) 3 mg
    Vitamin B2 (Riboflavin) 3 mg
    Vitamin B6 (Pyridoxine HCL) 20 mg
    Vitamin B12 (Cyanocobalamin) 15 mcg
    Folic Acid 1 mg
    Vitamin D3 (Cholecalciferol) 400 IU
    Vitamin C (Ascorbic Acid) 100 mg
    Vitamin E (d-alpha tocopherol) 30 IU
    Copper (Cupric Sulfate) 1 mg
    Zinc (Zinc Oxide) 20 mg
    Iron (Fumerate) 28 mg
    Magnesium 30 mg

    Rx Only

    Net Contents: 30 softgels

    Manufactured For:
    Centurion Labs LLC

    Distributed by:
    Centurion Labs LLC
    Birmingham, AL 35243

    PRINCIPAL DISPLAY PANEL - 30 tablets
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  • INGREDIENTS AND APPEARANCE
    C-NATE DHA 
    omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide capsule, gelatin coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23359-105
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 200 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 15 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 30 [iU]
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 28 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color BROWN (annato) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code PRE;01
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23359-105-30 30 in 1 BOTTLE
    2 NDC:23359-105-05 5 in 1 CARTON
    3 NDC:23359-105-01 1 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2013
    Labeler - Centurion Labs, LLC (806756461)
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