{"active_ingredient":["Active ingredient (in each tablet) Simethicone 80 mg"],"dosage_and_administration":["Directions chew or crush tablet completely before swallowing adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor. children under 12 years: ask a doctor"],"effective_time":"20250110","how_supplied":["HOW SUPPLIED Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with \"44 & 137\" on one side and are supplied as: NDC 57896-791-01 in bottle of 100 chewable tablets NDC 57896-791-08 in bottle of 80 chewable tablets Distributed by: GERI-CARE Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204"],"id":"2b5afc84-182d-07ef-e063-6294a90a9f3e","inactive_ingredient":["Inactive ingredients cellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, calcium phosphate."],"indications_and_usage":["Uses relieves pressure, bloating, 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"],"generic_name":["SIMETHICONE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000010282"],"original_packager_product_ndc":["57896-791"],"package_ndc":["71610-649-04"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["71610-649"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["314216"],"spl_id":["2b5afc84-182d-07ef-e063-6294a90a9f3e"],"spl_set_id":["5df94be7-0bc9-4be1-9982-8193e3a3c8ef"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 80 mg NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only Bottle Label 80 mg"],"purpose":["Purpose Anti-Gas"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"5df94be7-0bc9-4be1-9982-8193e3a3c8ef","spl_product_data_elements":["SIMETHICONE Simethicone CELLULOSE, MICROCRYSTALLINE DEXTRATES SILICON DIOXIDE TRICALCIUM PHOSPHATE STARCH, CORN CROSPOVIDONE MAGNESIUM STEARATE SUCRALOSE DIMETHICONE DIMETHICONE 44;137"],"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 71610-649-04 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 20220519JK Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count80 mg
471610-649-04
"],"storage_and_handling":["Other information each tablet contains: calcium 65 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature, 15°C - 30°C (59˚F - 86˚F) protect from moisture"],"version":"3","warnings":["Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children."]}