{"active_ingredient":["Active ingredient (in each capsule) Simethicone 125 mg"],"dosage_and_administration":["Directions adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime do not exceed 4 softgels per day unless directed by doctor"],"effective_time":"20241121","id":"2767d80e-d134-20a7-e063-6394a90aab4f","inactive_ingredient":["Inactive ingredients D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses for relief of: bloating pressure fullness stuffed feeling 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"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."],"nui":["N0000010282"],"package_ndc":["53345-009-01"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["53345-009"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198852"],"spl_id":["2767d80e-d134-20a7-e063-6394a90aab4f"],"spl_set_id":["0f9639fa-e1d0-460d-bc46-714a01cd9811"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"overdosage":["In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label SIMETHICONE CAPSULES, 125 mg Quantity : 25000 Capsules NDC. No : 53345-009-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" Shipping Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Antiflatulent"],"set_id":"0f9639fa-e1d0-460d-bc46-714a01cd9811","spl_product_data_elements":["Simethicone Simethicone SILICON DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 D&C YELLOW NO. 10 GELATIN GLYCERIN PEPPERMINT OIL TITANIUM DIOXIDE WATER DIMETHICONE DIMETHICONE OVAL PC2"],"stop_use":["Stop use and ask a doctor if condition persists."],"storage_and_handling":["Other information store at controlled room temperature 15°-30°C (59°-86°F) protect from heat and moisture do not use if imprinted safety seal under cap is broken or missing"],"version":"3","warnings":["Warnings Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}