{"active_ingredient":["Active Ingredients (in each softgel) Simethicone 125 mg"],"dosage_and_administration":["Directions adults: 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":"20250101","id":"2bd59ae1-05d2-f803-e063-6394a90adb88","inactive_ingredient":["D&C Yellow 10, FD&C Blue 1, Edible Ink, Gelatin, Glycerin, Peppermint oil, POLYSORB, Purified water, Titanium dioxide."],"indications_and_usage":["Use for the relief of pressure, bloating, 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"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"nui":["N0000010282"],"package_ndc":["80513-117-12"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["80513-117"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198852"],"spl_id":["2bd59ae1-05d2-f803-e063-6394a90adb88"],"spl_set_id":["5dcd50ae-370d-4e49-b981-db42b86c2ecb"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["NDC 80513-117-12 Extra Strength GAS RELIEF Simethicone 125 mg Bottle-label"],"purpose":["Purpose Antigas"],"questions":["Questions? call 1-800-630-8895"],"set_id":"5dcd50ae-370d-4e49-b981-db42b86c2ecb","spl_product_data_elements":["Gas Relief Simethicone D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN PEPPERMINT OIL WATER TITANIUM DIOXIDE DIMETHICONE DIMETHICONE 911"],"spl_unclassified_section":["Drug Facts","Distributed by: Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A."],"storage_and_handling":["Other Information store at 20° to 25°C (68° to 77°F) protect from light, heat and moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED"],"version":"1","warnings":["Warning If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children."]}