{"active_ingredient":["Active ingredient (in each softgel) Simethicone USP 125 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 4 softgels in 24 hours except under the advice and supervision of a physician"],"effective_time":"20260427","id":"5003982d-9100-ab86-e063-6394a90a83ce","inactive_ingredient":["Inactive ingredients D&C yellow no.10, FD&C blue no. 1, FD&C red no.40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide"],"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 Pvt Ltd"],"nui":["N0000010282"],"package_ndc":["35916-1938-1","35916-1938-2","35916-1938-3"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["35916-1938"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198852"],"spl_id":["5003982d-9100-ab86-e063-6394a90a83ce"],"spl_set_id":["32018302-7ce5-1f15-e063-6394a90ad378"],"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":["Principal Display Panel Compare to Gas-X ® Extra Strength Active Ingredient* NDC 35916-1938-2 Simethicone Capsules USP, 125 mg Simethicone 125 mg / Antigas (Relieves Gas Fast) Pressure, Bloating, Discomfort 30 Softgels bulk-label"],"purpose":["Purpose Antigas"],"set_id":"32018302-7ce5-1f15-e063-6394a90ad378","spl_product_data_elements":["Simethicone Simethicone D&C YELLOW NO. 10 DIMETHICONE DIMETHICONE TITANIUM DIOXIDE GELATIN PEPPERMINT OIL SORBITOL FD&C BLUE NO. 1 GLYCERIN WATER FD&C RED NO. 40"],"version":"4","warnings":["Warning"]}