{"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. of cool water, infant formula or other suitable liquids • clean dropper well after each use and replace original cap on bottle Age (years) Weight (lbs) 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=\"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 over 2</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>over 24</paragraph></td><td align=\"center\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>0.6 mL</paragraph></td></tr></tbody></table>"],"effective_time":"20260901","id":"5a661e89-7ee5-e3fd-e063-6294a90a24bb","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 ? Call toll-free 1-877-225-6999. Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 www.akronpharma.com"],"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":["TEENY TUMMY Gas Relief Drops"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Akron Pharma"],"nui":["N0000010282"],"package_ndc":["71399-0041-1"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["71399-0041"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["5a661e89-7ee5-e3fd-e063-6294a90a24bb"],"spl_set_id":["dcdd0daf-5ef0-4cb2-872d-89ed6e9f6d60"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"],"upc":["0371399004116"]},"package_label_principal_display_panel":["1 2"],"purpose":["Purpose Antigas"],"questions":["Questions or comments ? Call toll-free 1-877-225-6999. Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 www.akronpharma.com"],"set_id":"dcdd0daf-5ef0-4cb2-872d-89ed6e9f6d60","spl_product_data_elements":["TEENY TUMMY Gas Relief Drops Simethicone DIMETHICONE DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM"],"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."]}