{"active_ingredient":["Active ingredient (per 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":"20100209","id":"76774f7e-63c1-4ce3-8e70-07bb9408b59a","inactive_ingredient":["Inactive ingredients D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide"],"indications_and_usage":["Use 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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 125 mg Label SIMETHICONE CAPSULES USP 125MG Each Softgel Contains : (Simethicone USP 125 mg) LOT NO : QUANTITY : DRUM NO : NDC NO : 68210-1901- MFG DATE : EXP DATE : 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 - 125 mg Label"],"package_label_principal_display_panel_table":["
LOT NO : QUANTITY :
DRUM NO : NDC NO : 68210-1901-
MFG DATE : EXP DATE :
"],"purpose":["Purpose Antigas"],"set_id":"79eb60b1-f651-4f9c-8d20-a8eacfcfbbe8","spl_product_data_elements":["SIMETHICONE DIMETHICONE DIMETHICONE DIMETHICONE GLYCERIN GELATIN TITANIUM DIOXIDE WATER FD&C RED NO. 3 PEPPERMINT OIL FD&C BLUE NO. 1 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 light, heat and moisture"],"version":"1","warnings":["Warnings Keep out of reach of children."]}