{"active_ingredient":["ACTIVE INGREDIENT (IN EACH TABLET) SIMETHICONE 80MG"],"dosage_and_administration":["DIRECTIONS ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE. DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN."],"effective_time":"20240108","id":"0e765edc-264e-533a-e063-6394a90a7c53","inactive_ingredient":["INACTIVE INGREDIENTS DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE"],"indications_and_usage":["USES RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN."],"openfda":{"application_number":["M002"],"brand_name":["SIMETHICONE 80MG"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Gendose Pharmaceuticals, LLC"],"nui":["N0000010282"],"package_ndc":["77333-812-25","77333-812-10"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["77333-812"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["314216"],"spl_id":["0e765edc-264e-533a-e063-6394a90a7c53"],"spl_set_id":["e7f470cf-f036-afd9-e053-2995a90a9186"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["01b LBL_Simethicone_80mg_100 tablets"],"purpose":["PURPOSE ANTI-GAS"],"set_id":"e7f470cf-f036-afd9-e053-2995a90a9186","spl_product_data_elements":["SIMETHICONE 80MG SIMETHICONE MAGNESIUM STEARATE DEXTROSE MALTODEXTRIN TRIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE DIMETHICONE DIMETHICONE RP111"],"storage_and_handling":["OTHER INFORMATION EACH TABLET CONTAINS: CALCIUM 60MG STORE AT ROOM TEMPERATURE"],"version":"6","warnings":["WARNINGS GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222."]}