{"active_ingredient":["Active ingredient (per softgel) Simethicone 180 mg"],"dosage_and_administration":["Directions adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician"],"effective_time":"20091202","id":"ff5ca266-7b84-4f5c-8618-3b08556b964e","inactive_ingredient":["Inactive ingredients FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide"],"indications_and_usage":["Use for the relief of pressure and bloating commonly referred to as gas"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label SIMETHICONE CAPSULES USP 180MG Each Softgel Contains: (Simethicone USP 180 mg) LOT NO : MFG DATE : GROSS WT. : NDC NO : 68210-1902 QUANTITY : EXP DATE : CRTN : WARNING: KEEP OUT OF REACH OF CHILDREN STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C) PROTECT FROM LIGHT, MOISTURE AND FREEZING THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER. MANUFACTURED BY: SOFTGEL HEALTHCARE PVT LIMITED INDIA LABELLER CODE : 35916 LIC NO. : TN/DRUGS/00002124 MANUFACTURED FOR: SPIRIT PHARMACEUTICALS LLC 225 LINCOLN HWY, STE 205 FAIRLESS HILLS, PA 19030 PH.# 215 943 4000 FAX.# 215 943 4039 CAUTION : \"FOR MANUFACTURING, PROCESSING OR REPACKING\" PRINCIPAL DISPLAY PANEL - Shipping Label"],"purpose":["Purpose Antigas"],"set_id":"2700e23e-2dad-4b7d-a9e1-db21dfbf4f26","spl_product_data_elements":["SIMETHICONE DIMETHICONE DIMETHICONE DIMETHICONE GLYCERIN GELATIN TITANIUM DIOXIDE SORBITOL WATER HYPROMELLOSE FD&C YELLOW NO. 6 PEPPERMINT OIL P10"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information store at a controlled room temperature 20-25°C (68-77°F ) protect from heat and moisture"],"version":"1","warnings":["Warnings Keep out of reach of children."]}