{"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. * Percent Daily Values (DV) are based on a 2,000 calorie diet Supplement Facts Serving Size 1 Tablet Amount Per Serving % DV % DV for Pregnant and Lactating Women Vitamin A (100% as Beta-Carotene) 2500 IU 50 % 31 % Vitamin C 80 mg 133 % 133 % Vitamin D 3 400 IU 100 % 100 % Vitamin E 10 IU 33 % 33 % Thiamin (Vitamin B 1 ) 3 mg 200 % 176 % Riboflavin (Vitamin B 2 ) 3.4 mg 200 % 170 % Niacinamide 20 mg 100 % 100 % Vitamin B 6 20 mg 1000 % 800 % Folate 1 mg 250 % 125 % (L-methylfolate calcium 676 mcg (as Metafolin ® ) molar equivalent to 600 mcg of Folic Acid) (Folic acid, USP 400 mcg) Vitamin B 12 12 mcg 200 % 150 % Biotin 300 mcg 100 % 100 % Pantothenic acid 6 mg 60 % 60 % Calcium (calcium carbonate) 120 mg 12 % 9 % Iron (ferrous fumarate) 27 mg 150 % 150 % Iodine 150 mcg 100 % 100 % Magnesium 30 mg 8 % 7 % Zinc 15 mg 100 % 100 % Copper 2 mg 100 % 100 % Other Ingredients : ascorbyl palmitate, calcium sulfate, croscarmellose sodium, dicalcium phosphate, gelatin, hydrogenated soybean oil, hydrogenated vegetable oil, hypromellose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, mono and diglycerides, partially hydrogenated soybean oil, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, sodium aluminum silicate, sodium ascorbate, starch, stearic acid, sucrose, talc, titanium dioxide, and water. Metafolin ® (L-methylfolate calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than 1% D-methylfolate."],"description_table":["
* Percent Daily Values (DV) are based on a 2,000 calorie diet
Supplement Facts
Serving Size 1 Tablet
Amount Per Serving % DV % DV for Pregnant and Lactating Women
Vitamin A (100% as Beta-Carotene) 2500 IU 50 % 31 %
Vitamin C 80 mg 133 % 133 %
Vitamin D3 400 IU 100 % 100 %
Vitamin E 10 IU 33 % 33 %
Thiamin (Vitamin B1) 3 mg 200 % 176 %
Riboflavin (Vitamin B2) 3.4 mg 200 % 170 %
Niacinamide 20 mg 100 % 100 %
Vitamin B6 20 mg 1000 % 800 %
Folate 1 mg 250 % 125 %
(L-methylfolate calcium 676 mcg (as Metafolin®) molar equivalent to 600 mcg of Folic Acid)
(Folic acid, USP 400 mcg)
Vitamin B12 12 mcg 200 % 150 %
Biotin 300 mcg 100 % 100 %
Pantothenic acid 6 mg 60 % 60 %
Calcium (calcium carbonate) 120 mg 12 % 9 %
Iron (ferrous fumarate) 27 mg 150 % 150 %
Iodine 150 mcg 100 % 100 %
Magnesium 30 mg 8 % 7 %
Zinc 15 mg 100 % 100 %
Copper 2 mg 100 % 100 %
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician."],"effective_time":"20130909","how_supplied":["HOW SUPPLIED Child-resistant bottles of 90 tablets – NDC 59630-416-90 KEEP THIS AND ALL DRUGS OUT OF 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]."],"id":"c08c1d58-af48-4cb0-bdf0-072e3a8858cc","indications_and_usage":["INDICATIONS PRENATE ELITE ® is a multivitamin/multimineral nutritional 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":["PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label NDC 59630-416-90 Prenate Elite ® PRENATAL VITAMINS—FILM-COATED TABLETS With META FOLIN ® 90 Tablets Rx Only Manufactured for: SHIONOGI PHARMA, INC. Atlanta, GA 30328 Manufactured by: Pharmetics Inc. Laval, Quebec H7L 3H7 Made in Canada PNI-TL-2 Rev. 02/10 8633-1 PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label"],"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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"3d9c5ac1-2792-4814-8788-29b1594d4196","spl_product_data_elements":["Prenate Elite Vitamin A, Ascorbic Acid, Cholecalciferol, .Alpha-Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cyanocobalamin, Botin, Pantothenic Acid, Calcium Carbonate, Ferrous Fumarate, Iodine, Magnesium Oxide, Zinc Oxide, Cupric Oxide, and Levomefolaate Calcium VITAMIN A VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL THIAMINE Thiamine ION RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN PANTOTHENIC ACID PANTOTHENIC ACID CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION IODINE IODINE MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC CATION CUPRIC OXIDE CUPRIC CATION LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID ASCORBYL PALMITATE CALCIUM SULFATE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS GELATIN HYDROGENATED SOYBEAN OIL HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES CELLULOSE, MICROCRYSTALLINE COCO-GLYCERIDES POLYVINYL ALCOHOL POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE SODIUM ALUMINIUM SILICATE SODIUM ASCORBATE STARCH, CORN STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE WATER PN"],"spl_unclassified_section":["U.S. Patents #5,997,915; #6,011,040; #6,254,904; #6,441,168; #6,451,360; #6,673,381; #6,808,725 Prenate Elite ® 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, GA 30328 Manufactured by: Pharmetics, Inc. Laval, Quebec H7L 3H7 Made in Canada To report a serious adverse event or obtain product information, contact 1-800-849-9707 ext. 1454 PNI-PI-3 Rev. 02/10"],"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"}