{"active_ingredient":["Active Ingredient (in each 5 mL) Purpose Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant"],"ask_doctor":["Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"],"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 take evey 4 hours do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product Age Dose Adults and children 12 years and over 2 teaspoonful (10 mL) Children 6 to under 12 years 1 teaspoonful (5 mL) Children under 6 years Ask a doctor"],"dosage_and_administration_table":["
AgeDose
Adults and children 12 years and over2 teaspoonful (10 mL)
Children 6 to under 12 years1 teaspoonful (5 mL)
Children under 6 yearsAsk a doctor
"],"effective_time":"20250515","id":"352f8de3-8fcf-4098-e063-6294a90ace4d","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol."],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"keep_out_of_reach_of_children":["If pregnant or breast-feeding 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."],"openfda":{"application_number":["M012"],"brand_name":["DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69729-035-04","69729-036-04","69729-069-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69729-035","69729-036","69729-069"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["352f8de3-8fcf-4098-e063-6294a90ace4d"],"spl_set_id":["8bb85b23-e9f6-48c7-84b0-15e0e26df4c5"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0856828008557","0810053180501"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PENTREXCILINA CHILDREN PCNF","PRINCIPAL DISPLAY PANEL BROSOLVAN brosolvan","PRINCIPAL DISPLAY PANEL HISTIACIL HISTIACIL"],"purpose":["Relieves: • Chest congestion / Mucus • Cough"],"set_id":"8bb85b23-e9f6-48c7-84b0-15e0e26df4c5","spl_product_data_elements":["DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN ANHYDROUS CITRIC ACID GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN"],"spl_unclassified_section":["Questions or comments? Call 619-600-5632 Tamper evident: Do not use if inner seal under cap is broken or missing. Exclusively distributed by OPMX Chula Vista, CA91910 Phone: 619-600-5632 Manufactured in FDA Registered Facility In the USA"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information Store at 20°-25°C (68° -77°F). Do not refrigerate. Retain carton for future reference on full labeling"],"version":"6","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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"]}