{"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 green in color, opaque, and imprinted with 'Prenate' on one side and blank on the other. Supplement Facts Serving Size: 1 Softgel Amount per Serving: % Daily Value % Daily Value for Lactating Women Vitamin C (as ascorbic acid) 90 mg 150% 150% Vitamin D 3 (as cholecalciferol) 220 IU 55% 55% Vitamin E (as dl-alpha tocopheryl) 10 IU 33% 33% Vitamin B 6 (as pyridoxine HCl) 26 mg 1300% 1040% Folate (as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) 1 mg 250% 125% Vitamin B 12 (as cyanocobalamin) 13 mcg 217% 163% Biotin 280 mcg 93% 93% Calcium (as calcium carbonate) 145 mg 15% 11% Iron (as ferrous fumarate) 29 mg 161% 161% Iodine (as potassium iodine) 150 mcg 100% 100% Magnesium (as magnesium oxide) 50 mg 13% 11% Docosahexaenoic Acid (DHA) 300 mg Daily Value (DV) not established. Eicosapentaenoic Acid (EPA) 40 mg PRENATE ESSENTIAL ® contains fish oil and soy."],"description_table":["
Supplement Facts Serving Size: 1 Softgel
Amount per Serving: % Daily Value % Daily Value for Lactating Women
Vitamin C (as ascorbic acid) 90 mg 150% 150%
Vitamin D 3 (as cholecalciferol) 220 IU 55% 55%
Vitamin E (as dl-alpha tocopheryl) 10 IU 33% 33%
Vitamin B 6 (as pyridoxine HCl) 26 mg 1300% 1040%
Folate (as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) 1 mg 250% 125%
Vitamin B 12 (as cyanocobalamin) 13 mcg 217% 163%
Biotin 280 mcg 93% 93%
Calcium (as calcium carbonate) 145 mg 15% 11%
Iron (as ferrous fumarate) 29 mg 161% 161%
Iodine (as potassium iodine) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 50 mg 13% 11%
Docosahexaenoic Acid (DHA) 300 mg Daily Value (DV) not established.
Eicosapentaenoic Acid (EPA) 40 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20180814","how_supplied":["HOW SUPPLIED: Unit-dose packs of 30 softgels. (75854-303-30). The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems."],"id":"73678075-9b01-47ce-e053-2991aa0a4a43","inactive_ingredient":["OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, soy lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Yellow #5, FD&C Blue #1 and FD&C Yellow #6."],"indications_and_usage":["INDICATIONS: PRENATE ESSENTIAL ® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ESSENTIAL ® can also be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-303-30 30 Softgels PRENATE ESSENTIAL ® Rx prenatal vitamin & DHA Essential ® with Quatrefolic ® • Key vitamins, minerals, and DHA support nutrition Long lasting stability Improved bioavailability High water solubility Established safety Quatrefolic ® Rx Only Prenate DHA is a registered trademark of Acella Pharmaceuticals, LLC. *Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1 Under license from Acella Pharmaceuticals, LLC. All rights reserved. PRINCIPAL DISPLAY PANEL - 30 tablets"],"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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"09e2b1e8-94fa-4015-9cc4-9e81b605c6c0","spl_product_data_elements":["prenate essential - ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent YELLOW WAX CORN OIL LECITHIN, SOYBEAN GELATIN GLYCERIN WATER TITANIUM DIOXIDE FD&C YELLOW NO. 5 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE HYDROCHLORIDE 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 opaque Prenate"],"spl_unclassified_section":["Rx prenatal vitamin & DHA With Quatrefolic ® Rx Only","MANUFACTURED FOR: Avion Pharmaceuticals, LLC Atlanta, GA 30350 1-888-61-AVION *Quatrefolic® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1 PRENATE ESSENTIAL ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved. Rev. 021412 To learn more about your pregnancy, go to www.PrenatePERL.com"],"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.]"],"version":"4","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 Ration (INR). Administration 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."]}