{"active_ingredient":["Active ingredient (in each softgel) Simethicone USP 250 mg"],"dosage_and_administration":["Directions adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician"],"effective_time":"20260731","id":"57e5b6b1-0f79-5655-e063-6294a90ac944","inactive_ingredient":["Inactive ingredients D&C red no.33, FD&C blue no.1, gelatin, glycerin, purified water"],"indications_and_usage":["Use for the relief of pressure, bloating, and fullness commonly referred to as gas"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M002"],"brand_name":["Simethicone"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["SOFTGEL HEALTHCARE PRIVATE LIMITED"],"nui":["N0000010282"],"package_ndc":["35916-1940-1","35916-1940-2"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["35916-1940"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["412111"],"spl_id":["57e5b6b1-0f79-5655-e063-6294a90ac944"],"spl_set_id":["322e6cb3-0ddc-9300-e063-6294a90a972a"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"other_safety_information":["Other information store at controlled room temperature 20-25ºC (68-77ºF) protect from light, heat, and moisture"],"package_label_principal_display_panel":["label"],"purpose":["Purpose Antigas"],"set_id":"322e6cb3-0ddc-9300-e063-6294a90a972a","spl_product_data_elements":["Simethicone Simethicone DIMETHICONE DIMETHICONE WATER GELATIN D&C RED NO. 33 FD&C BLUE NO. 1 GLYCERIN SILICON DIOXIDE Transparent"],"version":"5","warnings":["Warnings"]}