{"active_ingredient":["Active ingredient (in each 0.3 mL) Simethicone 20 mg"],"dosage_and_administration":["Directions • shake well before using • all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day. • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids • clean dropper after each use - replace bottle with original cap age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"42%\"/><col width=\"35%\"/><col width=\"22%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>age (yr)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>weight (lb)</paragraph></td><td align=\"center\" styleCode=\"Botrule Toprule \" valign=\"top\"><paragraph>dose</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>infants under 2</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>under 24</paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"top\"><paragraph>0.3 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children over 2</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>over 24</paragraph></td><td align=\"center\" styleCode=\"Botrule \" valign=\"top\"><paragraph>0.6 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20230119","id":"6df3c764-5ee9-4e2f-b4d9-5282a9b951e5","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol."],"indications_and_usage":["Uses Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods"],"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":{},"package_label_principal_display_panel":["Principal Display Panel Compare to Infants' Mylicon Drops active ingredient Infants' Gas Relief Drops Anti-gas/Simethicone Non-Staining suitable for infant use no artificial colors no saccharin alcohol free 1 Fl. OZ (30ml) Leader Infants' Gas Relief"],"purpose":["Purpose Antigas"],"set_id":"41936f0b-c098-4958-83c7-35a664034930","spl_product_data_elements":["Leader Infants Gas Relief Simethicone DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE PEG-40 STEARATE POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL white to off white, opaque"],"storage_and_handling":["Other information • do not use in printed seal under cap is torn or missing • store at room temperature • do not freeze • see bottom panel for lot and expiration date"],"version":"4","warnings":["Warnings Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away."]}