{"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":"20130301","how_supplied":["HOW SUPPLIED Bottles of 30 softgel capsules (NDC 0245-0188-30). KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]"],"id":"5025b1da-ce29-4a86-860d-684da5123539","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 NDC 0245-0188-30 Rx ONLY DHA ONCE-DAILY PLANT-BASED DAILY-CAPSULE PreNexa ® Rx PRENATAL VITAMIN WITH PLANT-BASED DHA ESSENTIAL VITAMINS, MINERALS AND DHA WITH A GENTLE STOOL SOFTENER 30 SOFTGEL CAPSULES Principal Display Panel"],"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":"8189025b-d21d-405b-96d4-50a3428e9037","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. 10337 Revised 0909"],"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":"5","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."]}