{"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 any other syringe, dropper, spoon or dosing device when giving this medicine to your child. ▪ remove cap and insert syringe into the prescribed level. ▪ 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 (towards inner chick). ▪ 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%\"><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( mL)</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 </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</paragraph></td></tr></tbody></table>"],"effective_time":"20260903","id":"313ca52d-8692-43e8-beb2-7b4202f8022e","inactive_ingredient":["Inactive ingredients carboxymethylcellulose sodium, citric acid, natural flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum. Questions? 1-866-467-2748"],"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 sign or symptoms"],"openfda":{"application_number":["M002"],"brand_name":["Infants Gas Relief Drops"],"generic_name":["SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["DOLGENCORP INC"],"package_ndc":["55910-790-01"],"product_ndc":["55910-790"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198857"],"spl_id":["313ca52d-8692-43e8-beb2-7b4202f8022e"],"spl_set_id":["6b132ac0-e8eb-4199-85ad-5976558ee9c8"],"substance_name":["DIMETHICONE, UNSPECIFIED"],"unii":["92RU3N3Y1O"],"upc":["0368163709124"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55910-790-01 *Compare to active ingredient in infant’s Mylicon® Gas Relief* Infants' Gas Relief Simethicone Drops / Anti-gas • Dye- free • Non-staining formula Fast, effective relief of infants’ gas symptoms 1 FL. OZ. (30 mL) 100 doses DISTRIBUTED BY: OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 100% SATISFACTION GUARANTEED! (888) 309-9030 *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon ® Gas Relief. IMPORTANT: Keep this carton for future reference on full labeling DG Health Infants Gas Relief Simethicone"],"package_label_principal_display_panel_table":["<table width=\"32%\"><col width=\"32%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"unordered\"><item><caption> </caption><content styleCode=\"bold\">IMPORTANT:</content> Keep this carton for future reference on full labeling</item></list></td></tr></tbody></table>"],"purpose":["Purpose Antigas"],"questions":["Questions? 1-866-467-2748"],"set_id":"6b132ac0-e8eb-4199-85ad-5976558ee9c8","spl_product_data_elements":["Infants Gas Relief Drops Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM"],"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":"9","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 sign or symptoms"]}