{"active_ingredient":["In each 5 mL Dextromethorphan HBr - 5 mg Guaifenesin - 75 mg Phenylephrine HCl - 2.5 mg"],"dosage_and_administration":["Directions: Do not exceed 6 doses in 24 hour Age Dose Children 6 to under 12 years of age Take 2 teaspoonful (10 mL) every 4 hours Children 2 to under 6 years of age Take 1 teaspoonful (5 mL) every 4 hours Children under 2 years of age Ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\" border=\"02\"><caption/><tbody><tr><td> Age</td><td> Dose</td></tr><tr><td>Children 6 to under 12 years of age</td><td> Take 2 teaspoonful (10 mL) every 4 hours</td></tr><tr><td>Children 2 to under 6 years of age </td><td> Take 1 teaspoonful (5 mL) every 4 hours</td></tr><tr><td>Children under 2 years of age</td><td> Ask a doctor</td></tr></tbody></table>"],"effective_time":"20251231","id":"474629aa-619b-cf58-e063-6394a90abc92","inactive_ingredient":["Inactive ingredients: artificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose."],"indications_and_usage":["Uses temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Tusnel Pediatric DM"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Llorens Pharmaceutical International Division, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["54859-604-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["54859-604"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1119541"],"spl_id":["474629aa-619b-cf58-e063-6394a90abc92"],"spl_set_id":["63541753-de8d-42fe-a9b3-a5eac3fcdca4"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0354859604163"]},"package_label_principal_display_panel":["TusnelDMPED"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a doctor before use"],"purpose":["Purpose Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or Comments? 1-866-595-5598"],"set_id":"63541753-de8d-42fe-a9b3-a5eac3fcdca4","spl_product_data_elements":["Tusnel Pediatric DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl ANHYDROUS CITRIC ACID METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER TRISODIUM CITRATE DIHYDRATE SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"version":"5","warnings":["Warnings Do not use if your child is taking a 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 high blood pressure thyroid disease diabetes difficulty in urination due to enlargment of prostate gland a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor before use if your child is taking sedatives, tranquilizers or drugs for depression or MAOI drugs. Stop use and ask a doctor if your child gets nervousness, dizziness, or sleeplessness occur cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition."]}