{"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 doctor"],"effective_time":"20250109","id":"2b4cfbd3-496e-100d-e063-6294a90aba52","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":{"application_number":["M002"],"brand_name":["Simethicone"],"generic_name":["SIMETHICONE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000010282"],"original_packager_product_ndc":["54738-518"],"package_ndc":["71610-607-04"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["71610-607"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["314216"],"spl_id":["2b4cfbd3-496e-100d-e063-6294a90aba52"],"spl_set_id":["da0cc98e-1692-405a-ab81-420d6f9df6de"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 80 mg NDC 71610-607 - Simethicone 80 mg Chewable Tablets Bottle Label 80 mg"],"purpose":["Purpose Antiflatulent"],"questions":["Questions or Comments TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday"],"set_id":"da0cc98e-1692-405a-ab81-420d6f9df6de","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 71610-607-04 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 20211105JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count80 mg
471610-607-04
"],"version":"3","warnings":["Warnings If pregnant or breast-feeding, ask a health professional before use."]}