{"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™ Care One is a prenatal 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) 500 mg Docosahexaenoic Acid (DHA) 350 mg Eicosapentaenoic Acid (EPA) 100 mg Alpha-linolenic Acid (ALA) 50 mg Vitamins: Vitamin C (calcium ascorbate, USP and calcium threonate) 25 mg Vitamin D3 (cholecalciferol, USP) 800 IU Vitamin E (dl-alpha-tocopheryl acetate, USP) 15 IU Vitamin B2 (riboflavin, USP) 1.5 mg Vitamin B3 (niacinamide, USP) 10 mg Vitamin B6 (pyridoxine hydrochloride, USP) 50 mg Folic Acid, USP 1 mg Biotin, USP 300 mcg Minerals: Calcium (carbonate, USP) 100 mg Iron (elemental) Carbonyl iron, FCC 20 mg Ferrous aspartate and ferrous glycinate 7 mg Iodine (potassium iodide, USP) 150 mcg Magnesium (magnesium oxide, USP) 50 mg Zinc (zinc oxide, USP) 5 mg Other: Docusate Sodium, USP 50 mg INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil, flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium dioxide, silicon dioxide, and FD&C Red No. 40."],"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) 500 mg
Docosahexaenoic Acid (DHA) 350 mg
Eicosapentaenoic Acid (EPA) 100 mg
Alpha-linolenic Acid (ALA) 50 mg
Vitamins:
Vitamin C (calcium ascorbate, USP and calcium threonate) 25 mg
Vitamin D3 (cholecalciferol, USP) 800 IU
Vitamin E (dl-alpha-tocopheryl acetate, USP) 15 IU
Vitamin B2 (riboflavin, USP) 1.5 mg
Vitamin B3 (niacinamide, USP) 10 mg
Vitamin B6 (pyridoxine hydrochloride, USP) 50 mg
Folic Acid, USP 1 mg
Biotin, USP 300 mcg
Minerals:
Calcium (carbonate, USP) 100 mg
Iron (elemental)
Carbonyl iron, FCC 20 mg
Ferrous aspartate and ferrous glycinate 7 mg
Iodine (potassium iodide, USP) 150 mcg
Magnesium (magnesium oxide, USP) 50 mg
Zinc (zinc oxide, USP) 5 mg
Other:
Docusate Sodium, USP 50 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual dosage is one capsule daily, or as prescribed by a physician."],"effective_time":"20171220","general_precautions":["General Do not exceed recommended dosage. Folcaps™ Care One 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™ Care One prenatal multivitamin/mineral capsules are red soft gelatin capsules packaged in bottles of 30 capsules. (NDC: 68308-167-30) Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.] KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN."],"id":"7f0c4a43-cda3-4d2c-b1fc-b6cc6a06b550","indications_and_usage":["INTENDED USE Folcaps™ Care One 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 68308-167-30 30 Capsules Folcaps™ Care One DESCRIPTION: Folcaps™ Care One is a prenatal multivitamin/mineral capsule with omega-3 fatty acids. INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil, flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium dioxide, silicon dioxide, and FD&C Red No. 40. 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™ Care One 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":"1d2d220b-0e21-490b-b58d-f46683337f4d","spl_product_data_elements":["Folcaps Care One calcium ascorbate, calcium threonate, Cholecalciferol, ALPHA-TOCOPHERYL ACETATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CALCIUM CARBONATE, IRON, IODINE, MAGNESIUM, ZINC, DOCUSATE SODIUM, DOCONEXENT, ICOSAPENT, and LINOLENIC ACID calcium ascorbate ASCORBIC ACID CALCIUM CATION CALCIUM L-THREONATE CALCIUM CATION Cholecalciferol Cholecalciferol .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION IRON IRON IODINE IODINE MAGNESIUM MAGNESIUM ZINC ZINC DOCUSATE SODIUM DOCUSATE DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT LINOLENIC ACID LINOLENIC ACID GELATIN, UNSPECIFIED GLYCERIN SOYBEAN OIL FLAX SEED ETHYL VANILLIN LECITHIN, SOYBEAN YELLOW WAX TITANIUM DIOXIDE SILICON DIOXIDE FD&C RED NO. 40 ML;167"],"spl_unclassified_section":["Rx Only","","Manufactured for: Midlothian Laboratories Montgomery, AL 36117 Rev. 4/09"],"storage_and_handling":["Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.] 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."]}