{"active_ingredient":["Active Ingredient (in each 1 mL, dropperful) Purpose Dextromethorphan 4 mg............................................................................Cough Suppressant Guiafenesin 50 mg............................................................................Expectorant Phenylephrine HCl 2.5mg...................................................................Nasal Decongestant"],"dosage_and_administration":["Directions do not use more than doses in any 24-hour period repeat every 4 hours choose dosage by weight (if weight is not known, choose by age) measure with the dosing device provided. Do not use with any other device. Age Weight Dose 2 to under 6 years 24-47 Lbs 1 mL under 2 years under 24 Lbs ask as doctor"],"effective_time":"20250722","id":"3a8ae61d-30c1-903c-e063-6394a90ae5c2","inactive_ingredient":["Inactive ingradients citric acid, corn syrup, FD&C yellow #6, flavor, glycerin, guar gum,menthol, methylparaben, propylene glycol, propylparaben, sodium saccharin, sucralose, water"],"indications_and_usage":["Uses temporarily relives these symptoms occuring with cold: nasal congestion cough due to minor throat and bronchial irriatation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."],"keep_out_of_reach_of_children":["Keep ot of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Defensol-ito"],"generic_name":["DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE"],"is_original_packager":[true],"manufacturer_name":["Menper Distributors, Inc"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["53145-333-15"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["53145-333"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1661314"],"spl_id":["3a8ae61d-30c1-903c-e063-6394a90ae5c2"],"spl_set_id":["a7c7a60d-d49f-4239-92f7-714eac7eb0c5"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Defensol-ito Label"],"purpose":["Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern"],"set_id":"a7c7a60d-d49f-4239-92f7-714eac7eb0c5","spl_product_data_elements":["Defensol-ito Dextromethorphan, Guiafenesin, Phenylephrine CORN SYRUP FD&C YELLOW NO. 6 GLYCERIN GUAR GUM MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN CITRIC ACID MONOHYDRATE SACCHARIN SODIUM SUCRALOSE WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"version":"8","warnings":["Do not use in child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has heart disease thyroid disease cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with asthma high blood pressure diabetes When using this product, do not use more than directed Stop use and ask doctor if your child gets nervous, dizzy, or sleepless symptoms do not get better within 7 days, comes back, or is accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could b signs of a serious condition."]}