{"active_ingredient":["Active ingredient (in each softgel) Simethicone 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 physican"],"effective_time":"20251119","id":"95ba630a-b236-454f-9f29-e872a27d3103","inactive_ingredient":["Inactive ingredients D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide"],"indications_and_usage":["Uses 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":["Gas Relief Extra Strength"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"nui":["N0000010282"],"package_ndc":["0904-6994-46"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["0904-6994"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198852"],"spl_id":["95ba630a-b236-454f-9f29-e872a27d3103"],"spl_set_id":["4f445be1-220d-4660-abb2-c24cd33e7ca7"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"],"upc":["0309046994466"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Gas-X® Extra Strength† extra strength Gas Relief Simethicone 125 mg Antigas fast relief of: pressure bloating discomfprt small easy to swallow softgels †This product is not manufactured or distributed by Haleon group of companies distributor of Gas-X Extra Strength. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: MAJOR PHARMACEUTICALS Indianapolis, IN 46268","Product Label MAJOR Extra Strength Gas Relief Simethicone 125 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antigas"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"4f445be1-220d-4660-abb2-c24cd33e7ca7","spl_product_data_elements":["Gas Relief Extra Strength Simethicone DIMETHICONE DIMETHICONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN PEPPERMINT OIL WATER SORBITAN SORBITOL TITANIUM DIOXIDE MANNITOL PO"],"storage_and_handling":["Other information store between 20-25°C (68-77°F) do not refrigerate protect from light, heat, and moisture"],"version":"7","warnings":["Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children."]}