{"active_ingredient":["Active Ingredient (in each chewable tablet) Simethicone 80 mg"],"dosage_and_administration":["Directions chew thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician"],"effective_time":"20250528","id":"3635409d-509b-df95-e063-6294a90a9561","inactive_ingredient":["Inactive Ingredients dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid"],"indications_and_usage":["Uses relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing"],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 80mg NDC 67544-767 Simethicone (MTAB) 80mg - Rx Only Bottle Label 80mg"],"purpose":["Purpose Antiflatulent"],"questions":["Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc."],"set_id":"9e9f4c61-df0b-43c2-8887-2371cdd12ebc","spl_product_data_elements":["Simethicone Simethicone DEXTROSE SUCROSE MALTODEXTRIN PEPPERMINT SORBITOL STEARIC ACID DIMETHICONE DIMETHICONE AP;019"],"spl_unclassified_section":["Drug Facts .","Other Information store at room temperature 15-30 °C (59-86 °F) protect from moisture","Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 80 mg 4 67544-767-04 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20171222DKJ Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\" width=\"28%\"><col width=\"10%\"/><col/><tbody><tr styleCode=\"Toprule\"><td align=\"center\" styleCode=\"bold\" valign=\"bottom\">Count</td><td align=\"center\" valign=\"bottom\"><content styleCode=\"bold\">80 mg</content></td></tr><tr><td align=\"center\" valign=\"bottom\">4</td><td align=\"center\">67544-767-04</td></tr></tbody></table>"],"version":"3","warnings":["Warnings If pregnant or breast-feeding, ask a health professional before use."]}