{"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 fill enclosed dropper to recommended dosage level dispense liquid slowly into baby's mouth, toward the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids clean dropper after each use and close the bottle to maintain child resistance 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":["
age (yr)weight (lb)dose
infants under 2 under 240.3 mL
children over 2over 240.6 mL
"],"effective_time":"20241226","id":"edbc1a70-0fe7-42c4-a835-140c9f6aaf4a","inactive_ingredient":["INACTIVE INGREDIENTS SECTION benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum"],"indications_and_usage":["USE(S) relieves the symptoms of 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":["Infants Gas relief"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Topco Associates, LLC"],"nui":["N0000010282"],"package_ndc":["36800-119-09"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["36800-119"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["edbc1a70-0fe7-42c4-a835-140c9f6aaf4a"],"spl_set_id":["fd6a2537-8db2-492d-b045-6404df2fb9c3"],"substance_name":["DIMETHICONE"],"unii":["92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Topcare health COMPARE TO MYLICON ® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT* NDC 36800-119-09 NON-STAINING DYE-FREE infants' Gas Relief Drops SIMETHICONE 20 mg ANTI-GAS Gently Breaks Down Baby's Gas Bubbles Safe Enough to Use at Every Feeding** **use as directed 1 FL OZ (30 mL) 74"],"purpose":["PURPOSE Antigas"],"set_id":"fd6a2537-8db2-492d-b045-6404df2fb9c3","spl_product_data_elements":["Infants Gas relief Simethicone DIMETHICONE DIMETHICONE BENZOIC ACID MAGNESIUM ALUMINUM SILICATE WATER SORBITOL XANTHAN GUM off-white"],"storage_and_handling":["OTHER INFORMATION store at room temperature"],"version":"2","warnings":["WARNINGS When using this product do not exceed 12 doses per day"]}