{"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 DHA ® is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE DHA ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” 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 tocopherol) 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% Calcium (as calcium carbonate) 145 mg 15% 11% Iron (as ferrous fumarate) 28 mg 156% 156% Magnesium (as magnesium oxide) 50 mg 13% 11% Docosahexaenoic Acid (DHA) (from omega-3 fatty acids from fish oil) 300 mg Daily Value (DV) not established. PRENATE DHA® 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 tocopherol) 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%
Calcium (as calcium carbonate) 145 mg 15% 11%
Iron (as ferrous fumarate) 28 mg 156% 156%
Magnesium (as magnesium oxide) 50 mg 13% 11%
Docosahexaenoic Acid (DHA) (from omega-3 fatty acids from fish oil) 300 mg Daily Value (DV) not established.
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician."],"effective_time":"20180110","how_supplied":["HOW SUPPLIED: Unit-dose packs of 30 softgels. (75854-302-30). 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":"626f7350-9311-9386-e053-2a91aa0a6a36","inactive_ingredient":["OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, soy lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1 and FD&C Red #3."],"indications_and_usage":["INDICATIONS: PRENATE DHA ® 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 DHA ® 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 75854-302-30 30 Softgels Prenate Rx prenatal vitamin & DHA ® 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":"2d5a26a1-2617-4aa6-b764-b3bbcb433ed9","spl_product_data_elements":["PRENATE DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide and doconexent YELLOW WAX CORN OIL LECITHIN, SOYBEAN GELATIN GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION MAGNESIUM OXIDE MAGNESIUM CATION DOCONEXENT DOCONEXENT opaque DHA"],"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 DHA ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved. Rev. 021412"],"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":"5","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). 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."]}