{"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 • fill enclosed dropper to recommended dosage level • dispense liquid slowly into baby’s mouth, toward the inner cheek • may mix with 1 oz. of cool water, infant formula or other suitable liquids • clean dropper after each use and replace 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=\"27%\"/> <col width=\"23%\"/> <col width=\"15%\"/> <tbody> <tr> <td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>age (yr)</paragraph> </td> <td align=\"center\" styleCode=\"Botrule Lrule 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=\"Lrule Botrule \" valign=\"top\"> <paragraph>infants under 2</paragraph> </td> <td align=\"center\" styleCode=\"Lrule 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=\"Botrule Lrule \" valign=\"top\"> <paragraph>children over 2</paragraph> </td> <td align=\"center\" styleCode=\"Botrule Lrule \" 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":"20171119","id":"d8892dd4-0448-4660-a45f-cc095e1344c4","inactive_ingredient":["Inactive ingredients citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum"],"indications_and_usage":["Uses relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel Compare to active ingredient in Infants' Mylicon® Drops Non-Staining GAS RELIEF Infants' Drops Simethicone 20 mg / Anti-Gas Non-Staining Dye Free No Alcohol No Saccharin No Artificial Flavor No Artificial Colors GLUTEN FREE Gas Relief Carton Image 1 Gas Relief Carton Image 1 Gas Relief Carton Image 2 Gas Relief Carton Image 1 Gas Relief Carton Image 2"],"purpose":["Purpose Antigas"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"03097aa6-b255-4ca8-acf6-9813c42d3251","spl_product_data_elements":["rx act gas relief infants Simethicone DIMETHICONE DIMETHICONE SILICON DIOXIDE CITRIC ACID MONOHYDRATE HYPROMELLOSES MALTITOL WATER SODIUM BENZOATE SODIUM CITRATE SORBIC ACID XANTHAN GUM POLYETHYLENE GLYCOLS white to off white, opaque"],"storage_and_handling":["Other information store at room temperature (59°-86°F)"],"version":"2","warnings":["Warnings When using this product do not exceed 12 doses per day Keep out of reach of children."],"when_using":["When using this product do not exceed 12 doses per day"]}