{"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 THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately."],"contraindications":["CONTRAINDICATIONS PreNexa ® Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor."],"description":["DESCRIPTION PreNexa ® Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with plant-based DHA. Each softgel capsule is brown in color, opaque, and imprinted with \"PreNexa\". Each softgel capsule contains: Vitamin C (ascorbic acid, USP)………………………………….......…………………………..25 mg Calcium (tribasic calcium phosphate, NF)….....………………………………………….......…160 mg Iron (ferrous fumarate, USP)…………………………………...........…………………………..30 mg Vitamin D 3 (cholecalciferol, USP)…………………………….......…………………………….170 IU Vitamin E (d-alpha tocopherol, USP)…………….....…….....……………………..…...………..30 IU Vitamin B 6 (pyridoxine hydrochloride, USP)………………………....……...…...…..…………..25 mg Folic Acid, USP…………………………………………………….......…………….........…1.24 mg DHA (docosahexaenoic acid, contained in the oil derived from microalgae)……......…….....…...265 mg Docusate Sodium, USP…………………………………………………….............………...…55 mg Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide). Contains: Soy"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician."],"effective_time":"20130303","how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules (NDC 0245-0190-30). KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]"],"id":"eeb0af63-e72a-4ca7-b437-a3bf6607cd52","indications_and_usage":["INDICATIONS PreNexa ® Capsules are indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PreNexa ® may be useful in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Capsule Label NDC 0245-0190-30 Rx ONLY DAILY-CAPSULE PreNexa ® Rx PRENATAL VITAMIN WITH PLANT-BASED DHA ONCE-DAILY DHA PLANT BASED ESSENTIAL VITAMINS, MINERALS AND DHA WITH A GENTLE STOOL SOFTENER 30 SOFTGEL CAPSULES UPSHER SMITH PRINCIPAL DISPLAY PANEL - Capsule Label"],"precautions":["PRECAUTION 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 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"3cdbb3b0-6a82-4e53-9252-140d9d313ab0","spl_product_data_elements":["PreNexa Ascorbic Acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium Ascorbic Acid Ascorbic Acid tribasic calcium phosphate calcium cation ferrous fumarate ferrous cation cholecalciferol cholecalciferol .alpha.-tocopherol .alpha.-tocopherol pyridoxine hydrochloride pyridoxine folic acid folic acid doconexent doconexent docusate sodium docusate ethyl vanillin FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 gelatin glycerin lecithin, soybean palm kernel oil sodium benzoate soybean oil sunflower oil titanium dioxide yellow wax water ammonia isopropyl alcohol butyl alcohol propylene glycol DIMETHICONE PreNexa"],"spl_unclassified_section":["Rx only","Rx Prenatal Vitamin with plant-Based DHA 1.24 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid) Essential vitamins and minerals Gentle stool softener","CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","Distributed by: UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447 MADE IN CANADA 1-800-654-2299 www.upsher-smith.com US Patents 5,407,957; 5,492,938; 6,977,167. Other US Patents Pending. 103935-01 Revised 1109"],"storage_and_handling":["KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]"],"version":"2","warnings":["WARNING Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding."]}