{"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 below. If possible, use weight to dose; otherwise, use age. only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek). 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. dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids replace cap tightly to maintain child resistance mL = milliliter Age (yr) Weight (lb) Dose (mL) infants under 2 under 24 0.3 children over 2 over 24 0.6"],"dosage_and_administration_table":["<table width=\"100%\"><colgroup><col width=\"42%\"/><col width=\"36%\"/><col width=\"22%\"/></colgroup><tbody><tr><td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>Age (yr)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Weight (lb)</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Dose (mL)</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>infants under 2</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>under 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>0.3</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>children over 2</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>over 24</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>0.6</paragraph></td></tr></tbody></table>"],"effective_time":"20240101","id":"0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, D&C Red 22, D&C Red 28, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, 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. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M002"],"brand_name":["Mylicon Infants Gas Relief Original"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Infirst Healthcare"],"nui":["N0000010282"],"package_ndc":["62372-630-30","62372-630-15"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["62372-630"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857","809376"],"spl_id":["0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c"],"spl_set_id":["395be942-d883-4bcb-8811-6fe1521d5a92"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["Principal Display Panel Infants' Mylicon® Simethicone-Antigas Gas Relief Gently breaks down baby’s gas bubbles Original Drops Non-staining Safe enough to use at every feeding and up to 12 times per day* #1 Brand Recommended by Pediatricians 1 Fl. OZ (30ml) 100 Doses Visit us at mylicon.com No Alcohol No Artificial Flavors No Saccharin Gluten Free Safe enough to use at every feeding and up to 12 times per day* Safe enough for even the newest of newborns* *use as directed Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co. Important: Keep this carton for future reference on full labeling Manufactured for infirst Healthcare Inc. Westport, CT 06880 ©2015 infirst Healthcare Inc. Package Label for 30 mL Package Label for 15 mL Infants Mylicon Gas relief Original Infants Gas Relief Original Drops 15 mL"],"purpose":["Purpose Antigas"],"questions":["Questions or comments? Call 1-855-848-3284 toll free (English and Spanish)"],"set_id":"395be942-d883-4bcb-8811-6fe1521d5a92","spl_product_data_elements":["Mylicon Infants Gas Relief Original Simethicone CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ANHYDROUS CITRIC ACID D&C RED NO. 22 D&C RED NO. 28 MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM DIMETHICONE DIMETHICONE pink"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information tamper evident: do not use if printed seal under cap is broken or missing store between 20-25°C (68-77°F) do not freeze see bottom panel for lot number and expiration date"],"version":"5","warnings":["Warnings Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms."]}