{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitivity reactions and gastrointestinal disturbances may occur."],"contraindications":["CONTRAINDICATIONS Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and after pregnancy, one tablet daily, or as directed by a physician."],"effective_time":"20091210","how_supplied":["HOW SUPPLIED Renate is available as a dark pink caplet imprinted “RE316”: bottles of 100 caplets NDC 68032-316-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place. WARNING: Keep this and all drugs out of reach of children. Caution: Rx Only"],"id":"28c6a6d9-d7b2-4330-8a77-25891a118d7f","inactive_ingredient":["Other Ingredients Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Crospovidone, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sucrose, Polyethylene Glycol, Starch, Dicalcium Phosphate, Ascorbyl Palmitate, dl-alpha Tocopherol, Sodium Ascorbate, Titanium Dioxide, Carmine Powder, Gelatin, Hydrogenated Soybean Oil, Polysorbate, Riboflavin CFR73.45, Triacetin. May contain Povidone and Polydextrose. Contains NO artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk-based by-products. 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 a poison control center immediately. WARNING: Keep this and all drugs out of reach of children."],"indications_and_usage":["INDICATIONS AND USAGE Renate is indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception. Renate: Contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid."],"openfda":{},"package_label_principal_display_panel":["PACKAGING Sample Packaging: label"],"precautions":["PRECAUTIONS Folic acid (pteroylglutamic acid) and Vitamin B12 microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate, and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both. Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"set_id":"fb53de79-2adb-4ec1-8d59-1224843f82c9","spl_product_data_elements":["Renate Prenatal Multivitamin and Minerals BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM IRON IRON MAGNESIUM OXIDE MAGNESIUM ZINC OXIDE ZINC CUPRIC OXIDE CUPRIC CATION RE;316"],"version":"3","warnings":["WARNINGS 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 a poison control center immediately. WARNINGS: Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins."]}