{"active_ingredient":["Active ingredient (in each softgel) Simethicone 250 mg"],"dosage_and_administration":["Directions • Swallow one or two softgels as symptoms occur • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician"],"effective_time":"20240111","id":"fc6d5705-4d9a-4170-81ba-3ba12d99ace7","inactive_ingredient":["Inactive ingredients D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water"],"indications_and_usage":["Uses • relieves bloating, pressure or fullness commonly referred to as gas"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M002"],"brand_name":["Maximum Strength Gas Relief Softgel"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health 110, LLC. DBA Leader"],"nui":["N0000010282"],"package_ndc":["70000-0632-1"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["70000-0632"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["412111"],"spl_id":["fc6d5705-4d9a-4170-81ba-3ba12d99ace7"],"spl_set_id":["57043cae-a8db-4eff-835c-5995e8aea924"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"],"upc":["0096295142600"]},"package_label_principal_display_panel":["Packaging Cardnl-antigas-0632"],"purpose":["Purpose Anti-gas"],"questions":["Questions or comments? 1-888-577-8033 Monday- Friday 8am - 4pm EST"],"set_id":"57043cae-a8db-4eff-835c-5995e8aea924","spl_product_data_elements":["Maximum Strength Gas Relief Softgel Simethicone DIMETHICONE DIMETHICONE D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN WATER 813"],"spl_unclassified_section":["Drug Facts","LEADER ™ Relieves: Bloating Pressure Fullness COMPARE TO PHAZYME ® MAXIMUM STRENGTH active ingredient* 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme ® Maximum Strength. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners. Product of United Arab Emirates"],"storage_and_handling":["Other information • store at room temperature 20-25°C (68-77°F) • protect from heat, humidity and light"],"version":"4","warnings":["Warnings Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children."]}