{"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: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other. Supplement Facts Serving Size: 1 Tablet Amount per Serving: % Daily Value % Daily Value for Lactating Women Vitamin A (100% as beta-carotene) 2600 IU 50% 33% Vitamin C (as ascorbic acid) 75 mg 125% 125% Vitamin D 3 (as cholecalciferol) 450 IU 113% 113% Vitamin E (as dl-alpha tocopheryl acetate) 10 IU 33% 33% Thiamin (as thiamin mononitrate) 3 mg 200% 176% Riboflavin 3.5 mg 206% 175% Niacin (as niacinamide ) 21 mg 105% 105% Vitamin B 6 (as pyridoxine HCl) 21 mg 1050% 840% 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 330 mcg 110% 110% Pantothenic Acid (as calcium pantothenate) 6 mg 60% 60% Calcium (as calcium carbonate) 100 mg 10% 8% Iron (as ferrous fumarate) 26 mg 144% 144% Iodine (as potassium iodine) 150 mcg 100% 100% Magnesium (as magnesium oxide) 25 mg 6% 6% Zinc (as zinc oxide) 15 mg 100% 100% Copper (as copper oxide) 1.5 mg 75% 75%"],"description_table":["
Supplement Facts Serving Size: 1 Tablet
Amount per Serving: % Daily Value % Daily Value for Lactating Women
Vitamin A (100% as beta-carotene) 2600 IU 50% 33%
Vitamin C (as ascorbic acid) 75 mg 125% 125%
Vitamin D 3 (as cholecalciferol) 450 IU 113% 113%
Vitamin E (as dl-alpha tocopheryl acetate) 10 IU 33% 33%
Thiamin (as thiamin mononitrate) 3 mg 200% 176%
Riboflavin 3.5 mg 206% 175%
Niacin (as niacinamide ) 21 mg 105% 105%
Vitamin B 6 (as pyridoxine HCl) 21 mg 1050% 840%
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 330 mcg 110% 110%
Pantothenic Acid (as calcium pantothenate) 6 mg 60% 60%
Calcium (as calcium carbonate) 100 mg 10% 8%
Iron (as ferrous fumarate) 26 mg 144% 144%
Iodine (as potassium iodine) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 25 mg 6% 6%
Zinc (as zinc oxide) 15 mg 100% 100%
Copper (as copper oxide) 1.5 mg 75% 75%
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician."],"effective_time":"20180814","how_supplied":["HOW SUPPLIED: PRENATE ELITE ® is supplied in child-resistant bottles of 30 (75854-301-30) or child-resistant bottles of 90 tablets (75854-301-90). 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":"7366377f-924b-3909-e053-2a91aa0a4ece","inactive_ingredient":["OTHER INGREDIENTS: dicalcium phosphate, microcrystalline cellulose, stearic acid, aqueous coating, croscarmellose sodium, silica, magnesium stearate, titanium dioxide."],"indications_and_usage":["INDICATIONS: PRENATE ELITE ® is a multivitamin/multimineral 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 ELITE ® 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 75854-301-30 30 Tablets Prenate Elite TM PRENATAL VITAMINS-FILM-COATED TABLETS; DHA ® with Quatrefolic ® 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":"ae24a5b1-0688-4c76-ac39-770bb5377091","spl_product_data_elements":["Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE STEARIC ACID CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE TITANIUM DIOXIDE .BETA.-CAROTENE .BETA.-CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE THIAMINE ION RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM PANTOTHENATE PANTOTHENIC ACID CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC CATION PN"],"spl_unclassified_section":["PRENATAL VITAMINS-FILM COATED TABLETS 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 ELITE ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved. Rev. 022012"],"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":"6","warnings":["KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."]}