{"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, alter 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. of cool water, infant formula or other suitable liquids Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL children (2 and over) 24 and over 0.6 mL"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"42%\"/><col width=\"36%\"/><col width=\"22%\"/><tbody><tr><td align=\"center\" styleCode=\"Botrule Lrule Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Age (years)</content></paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Weight (lbs)</content></paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Dose</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule\" valign=\"top\"><paragraph>infants (under 2)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>under 24</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>0.3 mL</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule\" valign=\"top\"><paragraph>children (2 and over)</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>24 and over</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>0.6 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20260318","id":"4d4f1d08-e4ba-c0bc-e063-6294a90ae949","inactive_ingredient":["Inactive ingredients Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum. Questions or comments ? Distributed by: Atlantic Biologicals Corp. Miami, FL 33179"],"indications_and_usage":["Uses 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 INFANT Gas Relief Drops"],"generic_name":["SIMETHICONE"],"manufacturer_name":["Atlantic Biologicals Corp."],"nui":["N0000010282"],"original_packager_product_ndc":["82568-0017"],"package_ndc":["17856-1017-1","17856-1017-2","17856-1017-3","17856-1017-4","17856-1017-5","17856-1017-6","17856-1017-7","17856-1017-8","17856-1017-9"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["17856-1017"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["4d4f1d08-e4ba-c0bc-e063-6294a90ae949"],"spl_set_id":["410d80fc-e55b-08d0-e063-6294a90aba73"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["1 2 3 4 5 6 7 8"],"purpose":["Purpose Antigas"],"questions":["Questions or comments ? Distributed by: Atlantic Biologicals Corp. Miami, FL 33179"],"set_id":"410d80fc-e55b-08d0-e063-6294a90aba73","spl_product_data_elements":["SIMETHICONE INFANT Gas Relief Drops Simethicone CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM DIMETHICONE DIMETHICONE"],"storage_and_handling":["Other information TAMPER-EVIDENT : Do not use if printed seal under cap is broken or punctured store at room temperature do not freeze see bottom panel for lot number 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."]}