{"active_ingredient":["Active ingredient (in each 0.3 mL filled syringe) Simethicone 20 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 use other syringe, dropper, spoon or dosing device when giving this medicine to a child 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 mL = milliliter Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL"],"dosage_and_administration_table":["<table><col/><col/><col/><tbody><tr><td align=\"center\" styleCode=\" Botrule Toprule Lrule Rrule\"><content styleCode=\"bold\">Age (years)</content> </td><td align=\"center\" styleCode=\" Botrule Toprule Lrule Rrule\"><content styleCode=\"bold\">Weight (lbs) </content></td><td align=\"center\" styleCode=\" Botrule Toprule Lrule Rrule\"><content styleCode=\"bold\">Dose </content></td></tr><tr><td align=\"center\" styleCode=\" Botrule Toprule Lrule Rrule\"> infants (under 2) </td><td align=\"center\" styleCode=\" Botrule Toprule Lrule Rrule\"> under 24</td><td align=\"center\" styleCode=\" Botrule Toprule Lrule Rrule\"> 0.3 mL</td></tr></tbody></table>"],"effective_time":"20260603","id":"b858c7a8-bd06-4880-8c83-7c3a84f59592","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":["Infants Simethicone Drops"],"generic_name":["INFANTS SIMETHICONE DROPS"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"nui":["N0000010282"],"package_ndc":["0121-1094-01","0121-1094-03"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["0121-1094"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["b858c7a8-bd06-4880-8c83-7c3a84f59592"],"spl_set_id":["235f458e-c275-4bc1-9c0f-e007c4040649"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0121- 1094 -03 Compare to the ingredient of infants MYLICON®* Infants' Simethicone Drops DYE FREE 20 mg/0.3 mL Antigas Relieves the Symptoms Referred to as Gas PAI Pharma Each Box Contains 25 x 0.3 mL (0.01010 fl oz) Unit Dose Filled Syringes carton for Infants Simethicone Drops"],"purpose":["Purpose Antigas"],"questions":["Questions or comments? 1-800-845-8210"],"set_id":"235f458e-c275-4bc1-9c0f-e007c4040649","spl_product_data_elements":["Infants Simethicone Drops Infants Simethicone Drops DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MALTITOL MICROCRYSTALLINE CELLULOSE WATER SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts","Other information store at room temperature 15º-30ºC (59º-86ºF) protect from freezing do not use if wrapper containing syringe is torn or open"],"version":"1","warnings":["Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away."]}