{"active_ingredient":["Active ingredient (in each 0.3 mL) Simethicone 20 mg"],"dosage_and_administration":["Directions shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. only use the enclosed dropper. Fill dropper to the recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek. all dosages may be repeated as needed, after meals and at bedtime or as directed by a doctor do not exceed 12 doses per day 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 mL = milliliter"],"effective_time":"20260107","id":"47d51f3f-0474-a1bc-e063-6294a90a0e02","inactive_ingredient":["Inactive ingredients citric acid, hydroxypropyl methylcellulose, maltitol, natural flavor, purified water USP, sodium benzoate, sodium citrate, xanthan gum"],"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":{"application_number":["M002"],"brand_name":["QUITA COLICOS Gas RELIEF Drops"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["DLC Laboratories, Inc."],"nui":["N0000010282"],"package_ndc":["24286-1533-8"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["24286-1533"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["47d51f3f-0474-a1bc-e063-6294a90a0e02"],"spl_set_id":["d4b0fa36-5925-4a6f-b3c9-0c785503976f"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"],"upc":["0324286162406"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box De La Cruz ® Baby Gas Relief Drops Gotas Quita Cólicos ® Simethicone — ANTIGAS — Safe for newborns & infants No alcohol, No dyes, No saccharin Up To 100 Doses NATURAL CHERRY FLAVOR 1 FL OZ (30 mL) QuitaColicos-2"],"purpose":["Purpose Antigas"],"questions":["Questions 1-800-858-3889"],"set_id":"d4b0fa36-5925-4a6f-b3c9-0c785503976f","spl_product_data_elements":["QUITA COLICOS Gas RELIEF Drops Simethicone CITRIC ACID MONOHYDRATE HYPROMELLOSE, UNSPECIFIED MALTITOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM XANTHAN GUM DIMETHICONE DIMETHICONE"],"spl_unclassified_section":["Drug Facts","INFANTS (under 2 years): 0.3 mL CHILDREN (over 2 years): 0.6 mL AGE (years) WEIGHT (lbs.) DOSE INFANTS under 2 Under 24 lbs. 0.3 mL CHILDREN over 2 More than 24 lbs. 0.6 mL Image","Manufactured by : De La Cruz Products A Division of DLC Laboratories, Inc. Paramount, CA 90723 USA"],"spl_unclassified_section_table":["<table width=\"50%\"><col width=\"42%\" align=\"left\" valign=\"top\"/><col width=\"42%\" align=\"left\" valign=\"top\"/><col width=\"16%\" align=\"left\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\">AGE (years)</th><th styleCode=\"Rrule\">WEIGHT (lbs.)</th><th styleCode=\"Rrule\">DOSE</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">INFANTS under 2</td><td styleCode=\"Rrule\">Under 24 lbs.</td><td styleCode=\"Rrule\">0.3 mL</td></tr><tr><td styleCode=\"Lrule Rrule\">CHILDREN over 2</td><td styleCode=\"Rrule\">More than 24 lbs.</td><td styleCode=\"Rrule\">0.6 mL</td></tr></tbody></table>"],"storage_and_handling":["Other information do not use if printed bottle wrap is missing or broken store at room temperature do not freeze see bottom panel for lot number and expiration date"],"version":"8","warnings":["Warnings Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away."]}