{"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 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) .....................................................250 mg Eicosapentaenoic Acid (EPA).......................................................Not more than 0.625mg Calcium (Tricalcium Phosphate)...................................................100 mg Iron (Ferrous Fumarate) ..................................................................27 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 . The DHA in Natelle® One is derived from the oils of microalgae. Other 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":"20190130","geriatric_use":["Geriatric Use Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects."],"how_supplied":["HOW SUPPLIED Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with \"Natelle1\" in white ink, in bottles of 30 capsules (NDC 18860-852-01). Store at controlled room temperature 15°-30°C (59°-86°F)."],"id":"d1469c15-fb13-409a-8828-ca65487f97a5","indications_and_usage":["INDICATIONS AND USAGE Natelle® One is indicated to provide vitamin/mineral and 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":["BOTTLE LABEL Natelle One Bottle Label","STARTER KIT LABEL Natelle One Starter Kit Label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS Folic acid in doses above 0.1mg 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."],"set_id":"06b963be-0817-469e-ad3a-8096324fbe94","spl_product_data_elements":["Natelle One Natelle One DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT TRICALCIUM PHOSPHATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE .ALPHA.-TOCOPHEROL, D- .ALPHA.-TOCOPHEROL, D- FOLIC ACID FOLIC ACID GELATIN, UNSPECIFIED GLYCERIN YELLOW WAX HYDROGENATED SOYBEAN OIL LECITHIN, SOYBEAN TITANIUM DIOXIDE ETHYL VANILLIN oblong Natelle;1"],"spl_unclassified_section":["KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Distributed by: Azur Pharma, Inc. • 1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com To report a serious adverse event or obtain product information, contact (800) 890 3098. life’sDHA™ is a trademark of Martek Biosciences Corporation. Natelle® is a registered trademark of Pharmelle. Rx Only NAT1-09-01"],"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."]}