{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in RENAX ® 5.5."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS RENAX ® 5.5 is contraindicated In patients with hypersensitivity to any of its components."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION The process of dialysis causes vitamin/mineral losses necessitating the regular replacement of both. Vitamin A should not be supplemented. COMPOSITION Each caplet contains: Vitamin E................................................................. 351U Vitamin C................................................................. 100 mg Vitamin B 1 .............................................................. 3 mg Vitamin B 2 ............................................................. 2 mg Niacin (as Niacinamide) .......................................... 20 mg Folic Acid ............................................................... 5.5 mg Vitamin B 6 .............................................................. 30 mg Vitamin B 12 ............................................................ 1mg Biotin .................................................................... 300 mcg Pantothenic Acid ..................................................... 10 mg Zinc ....................................................................... 20 mg Selenium ............................................................... 70 mcg Inactive Ingredients : Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Hypromellose, Sodium Citrate, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, Mattodextrin, Triacetin"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One caplet daily or as prescribed by physician for patients on hemodialysis, RENAX ® 5.5 should be taken after treatment on Dialysis days or as directed by physician"],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions As little as 5 mg of Pyridoxine daily can decrease the efficacy of Levodopa in the treatment of Parkinsonism. Therefore, RENAX ® 5.5 is not recommended for patients undergoing such therapy. Drug/Laboratory Test Interactions","Drug Interactions As little as 5 mg of Pyridoxine daily can decrease the efficacy of Levodopa in the treatment of Parkinsonism. Therefore, RENAX ® 5.5 is not recommended for patients undergoing such therapy."],"effective_time":"20110321","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED White oblong film coated caplet imprint EV2755: NDC 0642-2755-90. Bottles of 90 Caplets. A childproof safety cap is standard on each bottle as a safeguard against accidental ingestion by children. Store at room temperature, 15 o -30 o C (59 o -86 o F)."],"id":"67f9176f-3b89-458f-8396-71c86a6c9053","indications_and_usage":["INDICATIONS AND USAGE RENAX ® 5.5 is a vitamin/mineral supplement to satisfy the nutritional needs of the Azotemic Patient with low levels of essential vitamins/mineral."],"information_for_patients":["Information for Patients"],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers"],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6944 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS Folic Acid may partially correct the hematological damage due to Vitamin B12 deficiency of Pernicious Anemia while the associated neurological damage progresses. Keep out of reach of General Information for Patients Laboratory Tests Interactions Drug Interactions As little as 5 mg of Pyridoxine daily can decrease the efficacy of Levodopa in the treatment of Parkinsonism. Therefore, RENAX ® 5.5 is not recommended for patients undergoing such therapy. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"67f9176f-3b89-458f-8396-71c86a6c9053","spl_product_data_elements":["RENAX OIL AND WATER SOLUBLE VITAMINS AND MINERALS .ALPHA.-TOCOPHEROL SUCCINATE, D- ALPHA-TOCOPHEROL ASCORBIC ACID ASCORBIC ACID THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACIN NIACINAMIDE FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-58 BIOTIN BIOTIN CALCIUM PANTOTHENATE CALCIUM PANTOTHENATE ZINC OXIDE ZINC OXIDE SODIUM SELENITE SELENIUM CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE PYRIDOXINE HYDROCHLORIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM CROSPOVIDONE MAGNESIUM STEARATE EV2755"],"spl_unclassified_section":["Vltamln-Mlneral Formulation to meet the Nutritional Needs of the Renal Patient."],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}