{"active_ingredient":["Active ingredients & Purposes . Active ingredients (in each 10 mL) Purposes Dextromethorphan HBr 20 mg....................Cough suppressant Guaifenesin 200 mg.............................................Expectorant Phenylephrine HCI 10 mg.........................Nasal decongestant"],"ask_doctor":["Ask a doctor before use if you have 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, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland"],"do_not_use":["Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions dosage cup included do not exceed 6 doses in 24 hours Age Dose adults and children 12 years and older take 10mL every 4 hours children under 12 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>adults and children 12 years and older</td><td> take 10mL every 4 hours</td></tr><tr><td>children under 12 years</td><td> consult a doctor</td></tr></tbody></table>"],"effective_time":"20260429","id":"509f6246-1393-fa9d-e063-6394a90a3681","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":["Broncomiel Adults"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["55758-512-08","55758-512-09"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55758-512"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1044949"],"spl_id":["509f6246-1393-fa9d-e063-6394a90a3681"],"spl_set_id":["509c61d3-ae16-be5c-e063-6294a90a68da"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","04JA59TNSJ","9D2RTI9KYH"]},"other_safety_information":["Other information each 10 mL contains: sodium 6 mg store between 68-77°F (20-25°C)"],"package_label_principal_display_panel":["Principal Display Panel PDP Broncomiel"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Active ingredients (in each 10 mL) Purposes Dextromethorphan HBr 20 mg....................Cough suppressant Guaifenesin 200 mg.............................................Expectorant Phenylephrine HCI 10 mg.........................Nasal decongestant"],"questions":["Questions? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com"],"set_id":"509c61d3-ae16-be5c-e063-6294a90a68da","spl_product_data_elements":["Broncomiel Adults 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 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 if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have 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, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if 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. If pregnant or breastfeeding, ask a health professional before use. 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"]}