{"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 physician"],"effective_time":"20250801","id":"3e0ea0d4-f46d-47be-b087-7e4538b22915","inactive_ingredient":["Inactive ingredients ammonium hydroxide, black iron oxide, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, 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":["TopCare health EXTRA STRENGTH Gas Relief SOFTGEL"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates LLC"],"package_ndc":["76162-538-05"],"product_ndc":["76162-538"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198852"],"spl_id":["3e0ea0d4-f46d-47be-b087-7e4538b22915"],"spl_set_id":["2ea0eb22-f679-d136-e063-6294a90a1dfe"],"substance_name":["DIMETHICONE, UNSPECIFIED"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["Packaging TCGasRelief"],"purpose":["Purpose Antigas"],"questions":["Questions? Call 1-888-423-0139"],"set_id":"2ea0eb22-f679-d136-e063-6294a90a1dfe","spl_product_data_elements":["TopCare health EXTRA STRENGTH Gas Relief SOFTGEL Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE AMMONIA FERROSOFERRIC OXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL BUTYL ALCOHOL PEPPERMINT OIL PROPYLENE GLYCOL SHELLAC SORBITOL SORBITAN TITANIUM DIOXIDE 911"],"spl_unclassified_section":["Drug Facts","COMPARE TO GAS-X ® EXTRA STRENGTH ACTIVE INGREDIENT* FAST RELIEF OF: Bloating Pressure Fullness & Gas KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO STVA0425 topcare@topco.com www.topcarebrand.com PRODUCT OF INDIA *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Gas-X ® . QUALITY GUARANTEED This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING"],"storage_and_handling":["Other information store at controlled room temperature 20-25°C (68-77°F) protect from light, heat and moisture"],"version":"2","warnings":["Warnings Keep out of reach of children."]}