{"active_ingredient":["Active ingredients ( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg"],"ask_doctor":["Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)"],"dosage_and_administration":["Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use"],"effective_time":"20250405","id":"f2b5fe0d-e42b-453f-920e-f7db45219f21","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)"],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA206941"],"brand_name":["Guaifenesin and Dextromethorphan HBr"],"generic_name":["GUAIFENESIN AND DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58602-825-65","58602-825-06"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58602-825"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1099074"],"spl_id":["f2b5fe0d-e42b-453f-920e-f7db45219f21"],"spl_set_id":["02d2a5a6-36bb-45b5-aba7-779615b276ed"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","9D2RTI9KYH"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 60 mg/1200 mg (42 Tablet Carton Label) NDC 58602-825-06 Primary Health COMPARE TO Maximum Strength Mucinex ® DM Active ingredients* MAXIMUM STRENGTH Mucus Relief DM Dextromethorphan HBr and Guaifenesin Extended-release Tablets 60 mg/1200 mg Dextromethorphan HBr 60 mg - Cough Suppressant Guaifenesin 1200 mg - Expectorant RELIEVES COUGH & CHEST CONGESTION √ Controls Cough √ Thins & Loosens Mucus ACTUAL SIZE 12 HOUR 42 Tablets Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (20 Tablet Carton Label)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions? call 1-855-274-4122"],"set_id":"02d2a5a6-36bb-45b5-aba7-779615b276ed","spl_product_data_elements":["Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K90 POVIDONE K25 STARCH, CORN white to off-white X;63"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness."],"storage_and_handling":["Other information store at 20° to 25°C (68° to 77°F)"],"version":"7","warnings":["Warnings Do not use for children under 12 years of age 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."],"when_using":["When using this product do not use more than directed"]}