{"active_ingredient":["Active ingredient (in each chewable tablet) Simethicone 125 mg"],"dosage_and_administration":["Directions thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more than 4 tablets per day"],"effective_time":"20250627","how_supplied":["How Supplied NDC 17856-0137-01 Box of 100 Chewable Tablets.................................. 17856-0137-01 ANTIFLATULENT"],"id":"38930d1f-1f60-1fa5-e063-6394a90a5c21","inactive_ingredient":["Inactive ingredients compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid"],"indications_and_usage":["Use relieves bloating, pressure 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":["Simethicone 125 mg"],"generic_name":["SIMETHICONE"],"manufacturer_name":["ATLANTIC BIOLOGICALS CORP."],"nui":["N0000010282"],"original_packager_product_ndc":["69618-032"],"package_ndc":["17856-0137-1","17856-0137-2"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["17856-0137"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["314221"],"spl_id":["38930d1f-1f60-1fa5-e063-6394a90a5c21"],"spl_set_id":["4ce98db3-c7a6-4627-88c5-9de302a53188"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["1"],"purpose":["Antiflatulent"],"questions":["Questions or comments? Distributed by: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179 Call 1-800-509-7592 M-F 8 am - 5 pm EST"],"set_id":"4ce98db3-c7a6-4627-88c5-9de302a53188","spl_product_data_elements":["Simethicone 125 mg Simethicone SUCROSE MALTODEXTRIN PEPPERMINT SORBITOL STEARIC ACID DEXTROSE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE DIMETHICONE DIMETHICONE Off white AP;040"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F)"],"version":"4","warnings":["Warnings Keep out of reach of children TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN"]}