{"active_ingredient":["Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 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)"],"do_not_use":["Do not use for children under12 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."],"dosage_and_administration":["Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regards for timing of meals adults and children 12 years of age and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use"],"effective_time":"20260210","id":"74767680-e4e7-4ba6-8d45-a01cd0471317","inactive_ingredient":["Inactive ingredients carbomer, colloidal silicon dioxide, D&Cyellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc"],"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 right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA209692"],"brand_name":["Maximum Strength Guaifenesin DM"],"generic_name":["GUAIFENESIN, DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["0536-1213-88"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["0536-1213"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1099074"],"spl_id":["74767680-e4e7-4ba6-8d45-a01cd0471317"],"spl_set_id":["2c9515f8-3120-4dbb-a7fc-d89fc5727148"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0305361213886"]},"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredients in Maximum Strength Mucinex® DM* Maximum strength Mucus Relief DM Guaifenesin | 1200 mg Expectorant Dextromethorphan HBr | 60 mg Cough Suppressant 12-hour relief Controls Cough Thins & Loosens Mucus Extended Release Tablets *This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex® DM. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com","Package Label RUGBY Maximum Strength Guaifenesin DM Dextromethorphan HBr 60 mg Guaifenesin 1200 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough Suppressant Expectorant"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"2c9515f8-3120-4dbb-a7fc-d89fc5727148","spl_product_data_elements":["Maximum Strength Guaifenesin DM Guaifenesin, Dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CARBOMER 934 SILICON DIOXIDE D&C YELLOW NO. 10 HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC AN039"],"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 between 20º to 25ºC (68º to 77ºF)"],"version":"9","warnings":["Warnings Do not use for children under12 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. 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) When using this product, do not use more than directed. 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. 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)."],"when_using":["When using this product, do not use more than directed."]}