{"active_ingredient":["Active ingredient (in each tablet) Simethicone 80 mg"],"dosage_and_administration":["Directions chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. do not exceed 6 tablets per day unless directed by a physician."],"effective_time":"20250606","id":"36ea951e-40b5-5fca-e063-6394a90af9fc","inactive_ingredient":["Inactive ingredients compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol"],"indications_and_usage":["Uses relieves: pressure bloating symptoms referred to as gas"],"keep_out_of_reach_of_children":["Enter section text here"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 80mg NDC 43353-325 Simethicone 80mg - Rx Only Bottle Label 80mg"],"purpose":["Purpose Antigas"],"questions":["Questions To Report Adverse Drug Event Call: (800) 616-2471"],"set_id":"f278e9ee-0c9e-495a-a916-ee9ffa8f9967","spl_product_data_elements":["Mi-Acid Gas Relief Simethicone SUCROSE DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE SORBITOL DIMETHICONE DIMETHICONE GDC103"],"spl_unclassified_section":["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 43353-325-04 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 20171030JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count80 mg
443353-325-04
"],"storage_and_handling":["Other information do not use if inner seal is broken. store at room temperature avoid high humidity and excessive heat, above 40 0 C (104 0 F)"],"version":"2","warnings":["Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center immediately."]}