{"active_ingredient":["Active ingredient (in each softgel) Simethicone 250 mg"],"dosage_and_administration":["Directions swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician"],"effective_time":"20241125","id":"27c7f645-cf9a-6db1-e063-6394a90a42ff","inactive_ingredient":["Inactive ingredients D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink"],"indications_and_usage":["Use 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":["Simethicone"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd"],"nui":["N0000010282"],"package_ndc":["53345-032-02"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["53345-032"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["412111"],"spl_id":["27c7f645-cf9a-6db1-e063-6394a90a42ff"],"spl_set_id":["0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label Simethicone Capsules 250 mg NDC 53345-032-02 Quantity: 12 Capsules per blister 124 Blisters per box IMPORTANT: Inspect immediately upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Shipping Label"],"purpose":["Purpose Anti-gas"],"set_id":"0c9c5fec-ddd4-41a5-8ff9-6b55c376dd36","spl_product_data_elements":["Simethicone Simethicone D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN GLYCERIN WATER DIMETHICONE DIMETHICONE clear oval PC31"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if condition persists"],"storage_and_handling":["Other information store at room temperature 59°-86°F (15°-30°C)"],"version":"3","warnings":["Warnings Stop use and ask a doctor if condition persists Keep out of reach of children."]}