{"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 years of age. Keep this product out of the 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 Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with \"Natelle1\" in white ink. Each capsule contains: Docosahexaenoic Acid (DHA) from Algal Oil..................................250 mg Eicosapentaenoic Acid (EPA).................................Not more than 0.625mg Calcium (Tricalcium Phosphate).......................................................102 mg Iron (Ferrous Fumarate) ...................................................................28 mg Vitamin C (Ascorbic Acid) ...............................................................30 mg Vitamin B-6 (Pyridoxine HCl) ...........................................................25 mg Vitamin E (D-Alpha Tocopherol) ......................................................30 IU Folic Acid ..........................................................................................1 mg DHA is an omega-3 fatty acid. 250 mg of DHA from 625 mg of algal oil is derived from Crypthecodinium cohnii. DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination. Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin."],"dosage_and_administration":["DOSAGE and ADMINISTRATION One capsule daily, or as directed by a physician."],"effective_time":"20150501","geriatric_use":["Geriatric Use Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8405 or 1-800-FDA-1088 or www.fda.gov/medwatch ."],"how_supplied":["HOW SUPPLIED Supplied in child resistant bottles of 30 capsules (NDC 0037-6072-30). Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). KEEP THIS AND ALL DRUGS/MEDICATIONS OUT OF THE REACH OF CHILDREN."],"id":"730ce5d5-4093-49cb-a6af-6fc447b74e6e","indications_and_usage":["INDICATIONS and USAGE Natelle® One is indicated to provide vitamin/mineral and DHA omega–3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® One may be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - BOTTLE LABEL 30 CAPSULES NDC 0037-6072-30 natelle ® ONE Rx Prenatal Vitamin &Plant-Based DHA. Now with 28 mg Iron Rx Only Distributed by: MEDA PHARMACEUTICALS™ Somerset, New Jersey 08873-4120 © 2013 Meda Pharmaceuticals Inc. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8405 or 1-800-FDA-1088 or www.fda.gov/medwatch . NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity. life’sDHA™ is a trademark of Martek Biosciences Corporation. natelle-label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. 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. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8405 or 1-800-FDA-1088 or www.fda.gov/medwatch ."],"set_id":"743244ce-428a-4714-bada-42d92cc27b39","spl_product_data_elements":["Natelle One doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT CALCIUM CALCIUM IRON IRON ASCORBIC ACID ASCORBIC ACID PYRIDOXINE PYRIDOXINE .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL FOLIC ACID FOLIC ACID GELATIN, UNSPECIFIED YELLOW WAX GLYCERIN SOYBEAN OIL LECITHIN, SOYBEAN TITANIUM DIOXIDE natelle1"],"spl_unclassified_section":["Rx Prenatal Vitamin & Plant-Based DHA. Now with 28 mg iron","BOXED WARNING","Distributed by: Meda Pharmaceuticals™ Somerset, New Jersey 08873-4120 © 2013 Meda Pharmaceuticals Inc. NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity. life’sDHA™ is a trademark of Martek Biosciences Corporation. Rx Only LB-607201-01 Rev. 10/2013"],"version":"2","warnings":["WARNINGS Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis."]}