{"active_ingredient":["ACTIVE INGREDIENT(in each tablet) Simethicone 80 mg"],"dosage_and_administration":["DIRECTIONS chew 2 to 4 tablets thoroughly as needed after meals and at bedtime do not exceed 6 tablets per day unless directed by a physician"],"effective_time":"20250110","how_supplied":["HOW SUPPLIED Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with \"G and 103\" on one side and are supplied as: NDC 0904-7206-60 in bottle of 100 chewable tablets Distributed by: Major Pharmaceuticals Livonia, MI 48152"],"id":"2b5b34d8-29c2-fc54-e063-6394a90aaa7a","inactive_ingredient":["INACTIVE INGREDIENTS compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol."],"indications_and_usage":["USE(S) relieves: pressure bloating symptoms referred to as gas"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"openfda":{"application_number":["M002"],"brand_name":["Antiflatulent"],"generic_name":["SIMETHICONE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000010282"],"original_packager_product_ndc":["0904-7206"],"package_ndc":["71610-650-04"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["71610-650"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["314216"],"spl_id":["2b5b34d8-29c2-fc54-e063-6394a90aaa7a"],"spl_set_id":["dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 80 mg NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only Bottle Label 80 mg"],"purpose":["PURPOSE Antigas"],"questions":["QUESTIONS Call (800) 616-2471"],"set_id":"dd2ca97e-89eb-4940-ac6e-abf1f9e1c6ea","spl_product_data_elements":["Antiflatulent Simethicone SUGARCANE MALTODEXTRIN DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SORBITOL DIMETHICONE DIMETHICONE G;103"],"spl_unclassified_section":["Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 80 mg 4 71610-650-04 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20220519JK Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count80 mg
471610-650-04
"],"storage_and_handling":["OTHER INFORMATION do not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)"],"version":"4","warnings":["WARNINGS ."]}