{"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 ® Star is a blue film coated tablet, engraved with “Prenate” on one side & “Star” on the other. Supplement Facts Serving Size: 1 Tablet Amount per Serving: Vitamin A (100% as beta-carotene) 3300 IU Vitamin C (as ascorbic acid) 75 mg Vitamin D3 (as cholecalciferol) 450 IU Thiamin (as thiamine mononitrate) 1.5 mg Riboflavin 2 mg Niacinamide 21 mg Vitamin B6 (as pyridoxine HCl) 21 mg Folic Acid USP 1 mg Vitamin B 12 (as cyanocobalamin) 12 mcg Biotin 330 mcg Pantothenic Acid (as calcium pantothenate) 6 mg Calcium (as Calcium Formate) “Formical ® \" 155 mg Iron (as Ferrous Asparto Glycinate) \"Sumalate ® \" 20 mg Iodine (as potassium iodide) 150 mcg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 15 mg Copper (as cupric oxide) 1.5 mg"],"description_table":["
Supplement Facts Serving Size: 1 Tablet Amount per Serving:
Vitamin A (100% as beta-carotene) 3300 IU
Vitamin C (as ascorbic acid) 75 mg
Vitamin D3 (as cholecalciferol) 450 IU
Thiamin (as thiamine mononitrate) 1.5 mg
Riboflavin 2 mg
Niacinamide 21 mg
Vitamin B6 (as pyridoxine HCl) 21 mg
Folic Acid USP 1 mg
Vitamin B 12 (as cyanocobalamin) 12 mcg
Biotin 330 mcg
Pantothenic Acid (as calcium pantothenate) 6 mg
Calcium (as Calcium Formate) “Formical ®" 155 mg
Iron (as Ferrous Asparto Glycinate) "Sumalate ®" 20 mg
Iodine (as potassium iodide) 150 mcg
Magnesium (as magnesium oxide) 25 mg
Zinc (as zinc oxide) 15 mg
Copper (as cupric oxide) 1.5 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician."],"effective_time":"20180110","how_supplied":["HOW SUPPLIED: Bottles of 30 tablets (75854-311-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems."],"id":"626f7350-9321-9386-e053-2a91aa0a6a36","inactive_ingredient":["OTHER INGREDIENTS: Cellulose, Silicon Dioxide, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide, FD&C Blue # 1, FD&C Blue # 2)."],"indications_and_usage":["INDICATIONS: PRENATE ® Star 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 ® Star 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 75854-311-30 Prenate ® Star Certified Kosher Rx Prenatal Vitamin Rx Only Dietary Supplement 30 Tablets Prenate® Star is Kosher Certified AVION PHARMACEUTICALS 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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"e853c0be-6cfb-4174-b020-1ea2bc35af1a","spl_product_data_elements":["Prenate Star .beta.-carotene, ascorbic acid, cholecalciferol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide POWDERED CELLULOSE SILICON DIOXIDE CROSCARMELLOSE SODIUM STEARIC ACID MAGNESIUM STEARATE HYPROMELLOSES TRIACETIN TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C BLUE NO. 2 .BETA.-CAROTENE .BETA.-CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM PANTOTHENATE PANTOTHENIC ACID CALCIUM FORMATE CALCIUM CATION FERROUS ASPARTO GLYCINATE FERROUS CATION POTASSIUM IODIDE IODIDE ION MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC CATION CUPRIC OXIDE CUPRIC CATION Prenate;Star"],"spl_unclassified_section":["Rx Only Dietary Supplement","THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542. Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956. PRENATE ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, Georgia 30022 1-888-61-AVION Rev. 0514"],"storage_and_handling":["STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"version":"3"}