{"active_ingredient":["Active ingredient (in each 5 mL cup) Purpose Guaifenesin 100 mg .............................................................................................................................. Expectorant Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant"],"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 Follow dosage below or use as directed by a physician.  do not take more than 6 doses in any 24-hour period.  single use cup. Dose only with cup provided.  each cup delivers 5 mL  mL = Milliliter Age (yr) Dose (mL) adults and children 12 years and over 10 mL every 4 hours children 6 years to under 12 years 5 mL every 4 hours children under 6 years of age ask a doctor"],"dosage_and_administration_table":["
Age (yr) Dose (mL)
adults and children 12 years and over10 mL every 4 hours
children 6 years to under 12 years 5 mL every 4 hours
children under 6 years of ageask a doctor
"],"effective_time":"20250129","how_supplied":["How Supplied Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form: NDC 0904-7512-41: 5 mL unit dose cup, in a tray of ten cups. Professional Note : Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). R10/24 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268"],"id":"7a9d1e3e-d1ad-4b40-9f77-6df15fecacc2","inactive_ingredient":["Inactive ingredients: anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, menthol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sucrose."],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold."],"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 (1-800-222-1222)"],"openfda":{"application_number":["M012"],"brand_name":["Guaifenesin and Dextromethorphan"],"generic_name":["GUAIFENESIN AND DEXTROMETHORPHAN"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["0904-7512-41","0904-7512-70"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["0904-7512"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["7a9d1e3e-d1ad-4b40-9f77-6df15fecacc2"],"spl_set_id":["97b137c9-0bec-409a-91f7-e298c296578b"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","9D2RTI9KYH"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0904-7512-41 GUAIFENESIN and DEXTROMETHORPHAN Syrup 100 mg/10 mg per 5 mL See Insert for Drug Facts For Institutional Use Only Guaifenesin and DM Syrup-Lid"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":["DRUG FACTS"],"questions":["Questions or comments? Call1-800-845-8210"],"set_id":"97b137c9-0bec-409a-91f7-e298c296578b","spl_product_data_elements":["Guaifenesin and Dextromethorphan Guaifenesin and Dextromethorphan GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID FD&C RED NO. 40 MENTHOL GLYCERIN WATER SACCHARIN SODIUM SUCROSE SODIUM BENZOATE SODIUM CITRATE"],"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  Each 5 mL contains: sodium 4 mg.  Store at 20° to 25°C (68° to 77°F). Protect from light."],"version":"4","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 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. 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 (1-800-222-1222)"]}