{"adverse_reactions":["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."],"contraindications":["CONTRAINDICATIONS RELNATE DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients."],"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 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."],"description_table":["
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
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose: one softgel daily or as prescribed by your doctor."],"drug_interactions":["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."],"effective_time":"20190306","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."],"how_supplied":["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"],"id":"83727c24-4a35-dde8-e053-2991aa0a1470","indications_and_usage":["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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Soft gel Bottle Label NDC 35573-200-30 R elnate 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"],"package_label_principal_display_panel_table":["
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
"],"pediatric_use":["PEDIACTRIC USE Safety and effectiveness in pediactric patients has not been established."],"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."],"set_id":"7c172c94-a5dc-4115-859f-02b7f40fb42b","spl_product_data_elements":["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 GELATIN GLYCERIN WATER BIXA ORELLANA SEED YELLOW WAX TITANIUM DIOXIDE OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN FOLIC ACID FOLIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ASCORBIC ACID ASCORBIC ACID ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL CUPRIC SULFATE ANHYDROUS CUPRIC CATION ZINC OXIDE ZINC OXIDE IRON IRON MAGNESIUM MAGNESIUM Annato colored PRE;01 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 GELATIN GLYCERIN WATER BIXA ORELLANA SEED YELLOW WAX TITANIUM DIOXIDE OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN FOLIC ACID FOLIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ASCORBIC ACID ASCORBIC ACID ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL CUPRIC SULFATE ANHYDROUS CUPRIC CATION ZINC OXIDE ZINC OXIDE IRON IRON MAGNESIUM MAGNESIUM Annato colored PRE;01"],"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","RX ONLY BUREL PHARMACEUTICALS JACKSON, MS 39218"],"spl_unclassified_section_table":["
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
"],"storage_and_handling":["Recommended Storage 59-86 degrees (F). Protect from light moisture and avoid excessive heat. Dispense original carton. KEEP OUT OF REACH OF CHILDREN"],"version":"3","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. 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."]}