Home > Drugs A-Z > RELNATE DHA

RELNATE DHA (Burel Pharmaceuticals, LLC)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 CARTON (35573-103-05) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (35573-103-30) Label Information

Complete RELNATE DHA Information

  • SPL UNCLASSIFIED SECTION

    PRENATAL / MULTIVITAMIN

    Rev. 3/11

    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 IU
    Vitamin E
      (d-alpha tocopherol)
    30 IU
    Mineral Copper
      (Sulfate)
    1 mg
    Zinc
      (Zinc Oxide)
    20 mg
    Iron
      (Fumerate)
    28 mg
    Magnesium 30 mg

    Rx ONLY


  • 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 IU
    Vitamin E
      (d-alpha tocopherol)
    30 IU
    Mineral Copper
      (Sulfate)
    1 mg
    Zinc
      (Zinc Oxide)
    20 mg
    Iron
      (Fumerate)
    28 mg
    Magnesium 30 mg

    INACTIVE INGREDIENTS

    Gelatin, Glycerine, purified water, annatto extract, lecithin, yellow beeswax, titanium dioxide.


  • INDICATIONS AND USAGE

    RELNATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of woman prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.


  • CONTRAINDICATIONS

    RELNATE DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients.


  • 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.


  • 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.

    PEDIACTRIC USE

    Safety and effectiveness in pediactric patients has not been established.

    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.


  • DRUG INTERACTIONS

    RELNATE DHA softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.


  • ADVERSE REACTION

    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.


  • DOSAGE AND ADMINISTRATION

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


  • HOW SUPPLIED

    RELNATE DHA is available as a Annato colored softgel, imprinted PRE 01. Available in 30 count bottles with NDC #35573-103-30 and sample cartons with NDC #35573-103-05.

    NDC # 35573-103-05 PHYSICIAN SAMPLE NOT FOR RESALE

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

    KEEP OUT OF REACH OF CHILDREN


  • SPL UNCLASSIFIED SECTION

    RX ONLY

    BUREL
    PHARMACEUTICALS
    JACKSON, MS 39218


  • PRINCIPAL DISPLAY PANEL - 30 Soft gel Bottle Label

    NDC 35573-200-30

    Relnate
    DHA

    Omega-3 Fatty Acids (DHA-EPA) 200 mg
    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 Soft gels

    PRINCIPAL DISPLAY PANEL - 30 Soft gel Bottle Label

  • INGREDIENTS AND APPEARANCE
    RELNATE DHA 
    omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, alpha-tocopherol, cupric sulfate anhydrous, zinc oxide, iron, and magnesium capsule, liquid filled
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-103
    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 - UNII:X66NSO3N35) THIAMINE MONONITRATE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 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 (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL 30 [iU]
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (SULFATE ION - UNII:7IS9N8KPMG) CUPRIC SULFATE ANHYDROUS 1 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 28 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Bixa Orellana Seed (UNII: O87354RZ5A)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color RED (Annato colored) 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:35573-103-05 1 in 1 CARTON
    1 NDC:35573-103-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/15/2011
    RELNATE DHA 
    omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, alpha-tocopherol, cupric sulfate anhydrous, zinc oxide, iron, and magnesium capsule, liquid filled
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-200
    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 - UNII:X66NSO3N35) THIAMINE MONONITRATE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 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 [iU]
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL 30 [iU]
    CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (SULFATE ION - UNII:7IS9N8KPMG) CUPRIC SULFATE ANHYDROUS 1 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 28 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Bixa Orellana Seed (UNII: O87354RZ5A)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color RED (Annato colored) 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:35573-200-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/15/2011
    Labeler - Burel Pharmaceuticals, LLC (002152814)