{"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)"],"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 Other information • Store between 20-25°C (68-77°F)"],"effective_time":"20221206","id":"801949ca-1baf-4a19-8466-91b4269a2c63","inactive_ingredient":["Inactive ingredients carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid"],"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":["ANDA214781"],"brand_name":["Guaifenesin and Dextromethorphan HBr"],"generic_name":["GUAIFENESIN AND DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["SUN PHARMACEUTICAL INDUSTRIES, INC."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63304-106-21","63304-110-54"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63304-106","63304-110"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1099074","1298324"],"spl_id":["801949ca-1baf-4a19-8466-91b4269a2c63"],"spl_set_id":["06328741-03e3-49cf-ae44-d4c2116e38a3"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 63304-110-14 Maximum Strength Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 1200 mg/60 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 14 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label","Package/Label Principal Display Panel NDC 63304-106-21 Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 600 mg/30 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 20 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label2"],"pregnancy_or_breast_feeding":["Pregnancy or Breast Feeding If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough suppressant Expectorant"],"set_id":"06328741-03e3-49cf-ae44-d4c2116e38a3","spl_product_data_elements":["Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SILICON DIOXIDE MALTODEXTRIN POVIDONE K30 STEARIC ACID off-white 054 Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) SILICON DIOXIDE MALTODEXTRIN POVIDONE K30 STEARIC ACID off-white 053"],"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."],"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. 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. Pregnancy or Breast Feeding 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"]}