{"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 reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"contraindications":["CONTRAINDICATIONS PRENATE ESSENTIAL is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION PRENATE ESSENTIAL™ is a prescription prenatal/postnatal multivitamin/mineral/ essential fatty acid softgel. Each softgel is blue-green in color, opaque, and imprinted with \"Prenate\" on one side. Percent Daily Values are based on a 2,000 calorie diet Supplement Facts Serving Size 1 Softgel Amount Per Serving: % DV For Adults % DV for Pregnant and Lactating Women Vitamin C 85 mg 142% 142% Vitamin D 3 200 IU 50% 50% Vitamin E 10 IU 33% 33% Vitamin B 6 25 mg 1250% 1000% Folate 1 mg 250% 125% (L-methylfolate as Metafolin 600 mcg) (folic acid, USP 400mcg) Vitamin B 12 12 mcg 200% 150% Biotin 250 mcg 83% 83% Calcium (calcium carbonate) 140 mg 14% 11% Iron (ferrous fumarate) 28 mg 156% 156% Iodine (potassium iodide) 150 mcg 100% 100% Magnesium (magnesium oxide) 45 mg 11% 10% Docosahexaenoic Acid (DHA) 300 mg Daily Value (DV) not established Eicosapentaenoic Acid (EPA) 40mg (from 340 mg omega-3 fatty acids from fish oil) Other Ingredients: fish oil, gelatin, hydrogenated vegetable oil, glycerin, sorbitol, beeswax, soy lecithin, titanium dioxide, vanillin, FD&C blue No. 1, propylene glycol, hypromellose."],"description_table":["
Percent Daily Values are based on a 2,000 calorie diet
Supplement Facts
Serving Size 1 Softgel
Amount Per Serving: % DV For Adults % DV for Pregnant and Lactating Women
Vitamin C 85 mg 142% 142%
Vitamin D3 200 IU 50% 50%
Vitamin E 10 IU 33% 33%
Vitamin B6 25 mg 1250% 1000%
Folate 1 mg 250% 125%
(L-methylfolate as Metafolin 600 mcg) (folic acid, USP 400mcg)
Vitamin B12 12 mcg 200% 150%
Biotin 250 mcg 83% 83%
Calcium (calcium carbonate) 140 mg 14% 11%
Iron (ferrous fumarate) 28 mg 156% 156%
Iodine (potassium iodide) 150 mcg 100% 100%
Magnesium (magnesium oxide) 45 mg 11% 10%
Docosahexaenoic Acid (DHA) 300 mg Daily Value (DV) not established
Eicosapentaenoic Acid (EPA) 40mg
(from 340 mg omega-3 fatty acids from fish oil)
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during, and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20130909","how_supplied":["HOW SUPPLIED Unit-dose packs of 30 softgels NDC # 59630-419-30 KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature] For inquiries call 1-800-849-9707 extension 1454."],"id":"b4aebae0-9ca7-4c89-a35f-df8309136dee","indications_and_usage":["INDICATIONS PRENATE ESSENTIAL is a multivitamin/mineral/essential fatty acid nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PRENATE ESSENTIAL can also be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgel Carton NDC-59630-419-30 30 Softgels Prenate ® Essential™ Rx prenatal vitamin & DHA Key vitamins, minerals, and DHA support nutrition With META FOLIN ® Rx Only US Patents #5,997,915;#6,254,904;#6,011,040;#6,451,360;#6,673,381;#6,808,725#6,441,168 Metafolin ® is a registered trademark of Merck KGaA, Darmstadt Germany ©2010 Shionogi Pharma, Inc. Atlanta, GA All rights reserved. Principal Display Panel - 30 Softgel Carton"],"precautions":["PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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":"6fc3cf68-c285-405d-bf39-5a3e78e5d4cf","spl_product_data_elements":["Prenate Essential Ascorbic Acid, Cholecalciferol, .Alpha-Tocopherol, Pyridoxine, Folic Acid, Cyanocobalamin, Biotin, Calcium carbonate, Ferrous fumarate, Potassium iodide, Magnesium oxide, Doconexent, Icosapent, and Levomefolate Calcium ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID GELATIN GLYCERIN SORBITOL YELLOW WAX LECITHIN, SOYBEAN TITANIUM DIOXIDE VANILLIN FD&C BLUE NO. 1 PROPYLENE GLYCOL HYPROMELLOSES blue-green Prenate"],"spl_unclassified_section":["PNE-PI-1 Rev. 02/10 U.S. Patents #5,997,915; # ,254,904; #6,011,040; #6,451,360; #6,673,381; #6,808,725; #6,441,168 Prenate Essential ® is a registered trademark of Shionogi Pharma, Inc. Metafolin ® is a registered trademark of Merck KGaA, Darmstadt Germany. ©2010 Shionogi Pharma, Inc. Atlanta, GA All rights reserved. Manufactured for: SHIONOGI PHARMA, INC. Atlanta, Georgia USA 30328 Manufactured by: Catalent Pharma Solutions, Swindon, UK. Made in the United Kingdom Prenate ® Essential™ Rx prenatal vitamin & DHA With META FOLIN ®"],"storage_and_handling":["Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature] For inquiries call 1-800-849-9707 extension 1454."],"version":"7","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). Administsration 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."]}