{"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, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards 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":["
Age (yr)Weight (lb)Dose (mL)
infants under 2under 240.3
children over 2over 240.6
"],"effective_time":"20251025","id":"41f5317f-a058-f03c-e063-6394a90a321a","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum Questions or comments? 1-800-645-2158"],"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":["Infants"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["RUGBY LABORATORIES"],"package_ndc":["0536-1303-75"],"product_ndc":["0536-1303"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["41f5317f-a058-f03c-e063-6394a90a321a"],"spl_set_id":["c6fa71bc-de48-47f4-80c4-7d92643d2664"],"substance_name":["DIMETHICONE, UNSPECIFIED"],"unii":["92RU3N3Y1O"],"upc":["0305361303754"]},"package_label_principal_display_panel":["Principal Display Panel Rugby ® Compare to the active ingredient in Infants’ Mylicon ® Drops* NDC 0536-1303-75 Infants’ Simethicone Drops Antigas Dye-free Non-staining formula No Saccharin No Artificial Color No Artificial Flavor 1 FL OZ (30 mL) 100 DOSES Distributed by: RUGBY LABORATORIES 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Syringe Enclosed. This bottle contains 100 doses (0.3 mL/dose) *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON ® Drops. Rugbt Infants Simethicone Drops"],"purpose":["Purpose Antigas"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"c6fa71bc-de48-47f4-80c4-7d92643d2664","spl_product_data_elements":["Infants Simethicone CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM DIMETHICONE, UNSPECIFIED DIMETHICONE"],"storage_and_handling":["Other information tamper evident: do not use if printed seal under cap is broken or missing Store at room temperature do not freeze see bottom panel for lot number and expiration date"],"version":"6","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."]}