{"active_ingredient":["Active ingredient (in each 0.6 mL unit-dose syringe) Simethicone 40 mg"],"dosage_and_administration":["Directions dose may be repeated as needed, after meals and at bedtime, or as directed by a physician only use the unit dose filled syringe. do not exceed 12 doses per day dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids discard syringe after use Age (years) Weight (lbs) Dose children (age 2 and over) 24 and over 0.6 mL"],"dosage_and_administration_table":["<table><col/><col/><col/><tbody><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Age (years)</content></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Weight (lbs) </content></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">Dose </content></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"> children (age 2 and over) </td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"> 24 and over</td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\"> 0.6 mL</td></tr></tbody></table>"],"effective_time":"20260902","id":"5a8782d0-df4d-f78b-e063-6394a90a6127","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum"],"indications_and_usage":["Use relieves the symptoms referred to as gas"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away."],"openfda":{"application_number":["M002"],"brand_name":["Simethicone Drops"],"generic_name":["SIMETHICONE DROPS"],"is_original_packager":[true],"manufacturer_name":["Everpharm LLC"],"nui":["N0000010282"],"package_ndc":["84415-003-01"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["84415-003"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["5a8782d0-df4d-f78b-e063-6394a90a6127"],"spl_set_id":["5a6d2c1f-4067-969f-e063-6394a90aa83f"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"],"upc":["0384415003017"]},"package_label_principal_display_panel":["Principal Display Panel NDC 84415-003-01 Simethicone (ENFIT) Oral Suspension, USP 40 mg/0.6 mL Distributed by: Everpharm LLC Marlborough MA 01752 50 UNITS x 0.6 mL pdp"],"purpose":["Purpose Antigas"],"questions":["Questions or comments? 1-866-838-3774"],"set_id":"5a6d2c1f-4067-969f-e063-6394a90aa83f","spl_product_data_elements":["Simethicone Drops Simethicone Drops DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID MALTITOL MICROCRYSTALLINE CELLULOSE WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts","Other information TAMPER-EVIDENT: Do not use if wrapper containing syringe is torn or open store at room temperature 20º-25ºC (68º-77ºF) do not freeze"],"version":"2","warnings":["Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away."]}