{"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) .........................................................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 . The DHA in Natelle ® One is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to 250 mg of DHA. 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":"20120629","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 Supplied in child resistant bottles of 30 capsules (NDC 18860-752-01). Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)."],"id":"47b93b9a-f622-4e5a-ae46-c57f44cc5544","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 30 Capsules NDC 18860-752-01 Natelle ® ONE Rx Prenatal Vitamin & Plant-Based DHA. Now with 28 mg Iron Rx Only Dist by: AZUR PHARMA INC. 1818 Market Street, Suite 2350 Philadelphia, PA 19103 www.azurpharma.com Mfg by: Accucaps Industries Ltd Windsor, Ontario, Canada Natelle ® is a registered trademark of Azur Pharma International II Limited. Bottle Label Principal Display Panel - Bottle Label","Principal Display Panel - Physician Sample Kit Natelle ® ONE Rx Prenatal Vitamin & Plant-Based DHA NDC 18860-752-00 ONE PHYSICIAN SAMPLING KIT Contains 10 Patient Starter Kits, each containing 3 capsules NOT FOR SALE RX ONLY Distributed by: AZUR PHARMA, INC. 1818 Market Street, Suite 2350 · Philadelphia, PA 19103 · www.azurpharma.com Manufactured by: Accucaps Industries Ltd. Windsor, Ontario, Canada Natelle ® is a registered trademark of Azur Pharma International II Limited. life'sDHA ™ is a trademark of Market Biosciences Corporation. Physicians Sample Kit Principal Display Panel - Physicians Sample"],"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."],"set_id":"7598030e-c345-49a1-9fbc-46b0cf7d6b16","spl_product_data_elements":["Natelle One doconexent,icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, and folic acid DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT TRICALCIUM PHOSPHATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL FOLIC ACID FOLIC ACID GELATIN, UNSPECIFIED GLYCERIN SOYBEAN OIL LECITHIN, SOYBEAN TITANIUM DIOXIDE ETHYL VANILLIN YELLOW WAX oblong Natelle1"],"spl_unclassified_section":["KEEP THIS AND ALL DRUGS/MEDICATIONS 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 Azur Pharma International II Limited. Rx Only NAT1w-11-01 life's DHA logo"],"version":"5","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."]}