{"active_ingredient":["Active ingredients & Purposes . Active ingredients (in each 2.5 mL) Purposes Dextromethorphan HBr 5 mg......................Cough suppressant Guaifenesin 50 mg...............................................Expectorant Phenylephrine HCI 2.5 mg........................Nasal decongestant"],"ask_doctor":["Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma"],"do_not_use":["Do not use in a 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 taking this product."],"dosage_and_administration":["Directions only use the dosage cup included do not exceed 6 doses in 24 hours Age Dose children 6 to under 12 years take 5 mL every 4 hours children 2 to under 6 years take 2.5 mL every 4 hours children under 2 years consult a doctor"],"dosage_and_administration_table":["<table border=\"0\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">Dose</content></td></tr><tr><td>children 6 to under 12 years</td><td>take 5 mL every 4 hours</td></tr><tr><td>children 2 to under 6 years</td><td>take 2.5 mL every 4 hours</td></tr><tr><td>children under 2 years</td><td>consult a doctor</td></tr></tbody></table>"],"effective_time":"20260623","id":"54ec4c3c-358a-2601-e063-6294a90afcf8","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum"],"indications_and_usage":["Uses Temporarily relieves common cold symptoms: stuffy nose nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive"],"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":["M012"],"brand_name":["Broncolito Children"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["55758-520-08"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55758-520"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1044949"],"spl_id":["54ec4c3c-358a-2601-e063-6294a90afcf8"],"spl_set_id":["509f5b72-9894-ef44-e063-6394a90a6d07"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","04JA59TNSJ","9D2RTI9KYH"]},"other_safety_information":["Other information each 2.5 mL contains: sodium 1.5 mg store between 68-77°F (20-25°C)"],"package_label_principal_display_panel":["Principal Display Panel PDP Broncolito"],"purpose":["Active ingredients (in each 2.5 mL) Purposes Dextromethorphan HBr 5 mg......................Cough suppressant Guaifenesin 50 mg...............................................Expectorant Phenylephrine HCI 2.5 mg........................Nasal decongestant"],"questions":["Questions? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com"],"set_id":"509f5b72-9894-ef44-e063-6394a90a6d07","spl_product_data_elements":["Broncolito Children Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride ANHYDROUS CITRIC ACID HONEY SUCRALOSE XANTHAN GUM SORBITOL SOLUTION FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL SODIUM BENZOATE WATER GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Amber to yellow"],"spl_unclassified_section":["Drug Facts .","Dist by/ por: PHARMADEL LLC New Castle, DE 19720"],"stop_use":["Stop use and ask a doctor if your child has nervousness, dizziness, or sleeplessness occur a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"version":"2","warnings":["Warnings . Do not use in a 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 taking this product. Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma When using this product do not exceed recommended dosage Stop use and ask a doctor if your child has nervousness, dizziness, or sleeplessness occur a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not exceed recommended dosage"]}