{"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. 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."],"description":["DESCRIPTION Natelle ® Complete capsules for oral administration are supplied as oblong pink soft gelatin capsules, imprinted with \"nComplete\" in white ink. Each capsule contains: Docosahexaenoic Acid (DHA) from Algal Oil.........................................................250 mg Eicosapentaenoic Acid (EPA) ....................................................... Not more than 0.625 mg Calcium (Tricalcium Phosphate).................................................................................100 mg Iron (Ferrous Fumarate) .................................................................................................30 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 Vitamin D (Cholecalciferol) ........................................................................................... 400 IU DHA is an omega-3 fatty acid . The DHA in Natelle ® Complete is derived from Algal Oil (C. cohnii). Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin, D&C Red #33, FD&C Red#40."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One capsule daily, or as directed by a physician."],"effective_time":"20111018","how_supplied":["HOW SUPPLIED Supplied in child resistant bottles of 30 capsules (NDC 18860-652-01). Store at controlled room temperature 15°-30°C (59°-86°F). 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 NTCMw-10-01 life's DHA symbol"],"id":"ebce3700-7c20-4580-a485-a086c90fddc0","indications_and_usage":["INDICATIONS AND USAGE Natelle ® Complete 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 ® Complete may be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Physician Starter Kit Front Carton Label Physician Starter Kit Front Carton Label natelle ® COMPLETE All-in-one Rx prenatal vitamin with plant-based DHA A complete formulation for you and your baby. 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 Pharmelle. life'sDHA ™ is a trademark of Martek Biosciences Corporation. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Physician Starter Kit Front Carton Label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Physician Starter Kit Left-Side Carton Label Physician Starter Kit Left-Side Carton Label natelle ® COMPLETE All-in-one Rx prenatal vitamin with plant-based DHA NDA 18860-652-00 ONE PHYSICIAN SAMPLING KIT Contains 10 Patient Starter Kits, each containing 3 capsules NOT FOR SALE RX ONLY PRINCIPAL DISPLAY PANEL - Physician Starter Kit Left-Side Carton Label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Bottle Label Bottle Label 30 CAPSULES 18860-652-01 Rx Only natelle ® COMPLETE All-in-one Rx prenatal vitamin with plant-based DHA Dist by: AZUR PHARMA, INC. 1818 Market Street, Suite 2350 Philadelphia, PA 19103 www.azurpharma.com Mfg by: Accucaps Industries, Ltd. Windsor, Ontario, Canada To report a serious adverse event or obtain product information, contact (800) 890 3098. Natelle ® is a registered trademark of Pharmelle. life'sDHA ™ is a trademark of Martek Biosciences Corporation. Bottle Label"],"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. Other sources of folic acid are leafy vegetables, fortified cereals and bread. Causes of neural tube defect are multifactorial and folic acid supplements alone may not prevent these birth defects. 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":"5a9b0990-cd8c-41bf-8ff7-d4de3ebad240","spl_product_data_elements":["natelle COMPLETE Docosahexaenoic Acid, Eicosapentaenoic Acid, Calcium, Iron, Vitamin C, Vitamin B-6, Vitamin E, Folic Acid and Vitamin D DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT TRICALCIUM PHOSPHATE CALCIUM FERROUS FUMARATE IRON ASCORBIC ACID ASCORBIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL FOLIC ACID FOLIC ACID CHOLECALCIFEROL CHOLECALCIFEROL GELATIN GLYCERIN SOYBEAN OIL LECITHIN, SOYBEAN TITANIUM DIOXIDE ETHYL VANILLIN YELLOW WAX D&C RED NO. 33 FD&C RED NO. 40 oblong nComplete"],"version":"3","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."]}