{"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. cool water, infant formula or other suitable liquids ▪ clean dropper after each use - replace bottle with 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=\"42%\"/><col width=\"36%\"/><col width=\"22%\"/><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":"20241028","id":"2b8605c2-dcb3-48e0-ac8e-9c583d0a758d","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, 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. In case of overdose get medical help or contact a poison control center right away."],"openfda":{"application_number":["M002"],"brand_name":["premier value infants gas relief"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Chain Drug Consortium"],"package_ndc":["68016-670-00"],"product_ndc":["68016-670"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["2b8605c2-dcb3-48e0-ac8e-9c583d0a758d"],"spl_set_id":["7b887e53-a70a-4f33-9472-e1175b24400a"],"substance_name":["DIMETHICONE, UNSPECIFIED"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS* Premier Value ® Infants' Gas Relief Non-Staining formula Simethicone 20 mg/Antigas • Dye Free • No Saccharin • No Artificial Colors • No Artificial flavors Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose) 1 Fl. OZ (30ml) 100 Doses Distributed by Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon ® Drops. Premier Value Infants' Gas Relief Permier Value Infants' Gas Relief"],"purpose":["Purpose Antigas"],"set_id":"7b887e53-a70a-4f33-9472-e1175b24400a","spl_product_data_elements":["premier value infants gas relief Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM white to off white, opaque"],"storage_and_handling":["Other information ▪ tamper evident: do not use if printed seal under cap is torn or missing ▪ store at room temperature ▪ do not freeze ▪ see bottom panel for lot 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."]}