{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["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."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["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: Essential Fatty Acids: Omega-3 Fatty Acids The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil. (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."],"description_table":["
Essential Fatty Acids:
Omega-3 Fatty Acids The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil. (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
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual dosage is one capsule daily, or as prescribed by a physician."],"effective_time":"20171214","general_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."],"geriatric_use":["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."],"how_supplied":["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."],"id":"cd3900eb-1d70-4f05-8d66-0bf05b30fe83","indications_and_usage":["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."],"openfda":{},"package_label_principal_display_panel":["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"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["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."],"set_id":"d09b56a1-d301-49a2-a06f-f3e4e3e52e6e","spl_product_data_elements":["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 CALCIUM ASCORBATE ASCORBIC ACID CALCIUM CATION CALCIUM L-THREONATE CALCIUM CATION THREONIC ACID, L- CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CALCIUM CALCIUM IRON IRON FERROUS ASPARTO GLYCINATE FERROUS CATION DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT LINOLENIC ACID LINOLENIC ACID GELATIN, UNSPECIFIED GLYCERIN YELLOW WAX SILICON DIOXIDE WATER LECITHIN, SOYBEAN TITANIUM DIOXIDE FD&C RED NO. 40 ETHYL VANILLIN CORN OIL"],"spl_unclassified_section":["Rx Only"],"storage_and_handling":["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."],"version":"2","warnings":["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.","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."]}