{"active_ingredient":["DRUG FACTS 10 mg-100 mg/5 mL - Active ingredient per 5 mL (1 unit dose) Dextromethorphan HBr. 10 mg Guaifenesin 100 mg 20 mg-200 mg/10 mL - Active ingredient per 10 mL (1 unit dose) Dextromethorphan HBr. 20 mg Guaifenesin 200 mg"],"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 • do not take more than 6 doses in any 24 hour period 20 mg-200 mg/10 mL age dose Children under 12 years of age Do not use Adults and children over 12 years of age 10 mL (1 unit dose) every 4 hours 10 mg-100 mg/5 mL age dose Children under 6 years of age Do not use Children 6 to under 12 years of age 5 mL (1 unit dose) every 4 hours Adults and children over 12 years of age 10 mL (2 unit dose) every 4 hours"],"dosage_and_administration_table":["
agedose
Children under 12 years of ageDo not use
Adults and children over 12 years of age10 mL (1 unit dose) every 4 hours
","
agedose
Children under 6 years of ageDo not use
Children 6 to under 12 years of age5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age10 mL (2 unit dose) every 4 hours
"],"effective_time":"20250116","id":"2bda25ff-9e45-8f8d-e063-6294a90a6a0f","inactive_ingredient":["Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose."],"indications_and_usage":["Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"openfda":{"application_number":["M012.85","M012"],"brand_name":["Dextromethorphan HBr. and Guaifenesin"],"generic_name":["DEXTROMETHORPHAN HBR. AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Everpharm LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["84415-014-01","84415-011-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["84415-011","84415-014"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["2bda25ff-9e45-8f8d-e063-6294a90a6a0f"],"spl_set_id":["0c7cd5c4-459d-4e42-ae22-b94f2e29cffb"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"other_safety_information":["Other Information • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid is torn or broken"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL EverPharm NDC 84415-014-01 Dextromethorphan HBr. and Guaifenesin Oral Solution Cough Suppressant/ Expectorant 10 mg-100 mg/5 mL • Alcohol Free • Sugar Free • Cherry Flavor For Institutional Use Only 100 x 5 mL Unit-Dose Cups 10label","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL EverPharm NDC 84415-011-01 Dextromethorphan HBr. and Guaifenesin Oral Solution Cough Suppressant/ Expectorant 20 mg-200 mg/10 mL • Alcohol Free • Sugar Free • Cherry Flavor For Institutional Use Only 100 x 10 mL Unit-Dose Cups 5label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a healthcare professional before use."],"purpose":["Purpose Cough Suppressant Expectorant"],"questions":["Questions or comments? Call (866) 838-3774"],"set_id":"0c7cd5c4-459d-4e42-ae22-b94f2e29cffb","spl_product_data_elements":["Dextromethorphan HBr. and Guaifenesin Dextromethorphan HBr. and Guaifenesin ANHYDROUS CITRIC ACID FD&C RED NO. 4 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN Dextromethorphan HBr. and Guaifenesin Dextromethorphan HBr. and Guaifenesin ANHYDROUS CITRIC ACID FD&C RED NO. 4 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition."],"version":"1","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 persistant headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}