{"active_ingredient":["Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with 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."],"dosage_and_administration":["Directions do not take more than 6 doses in 24-hour period measure only with dosing coup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours Children under 12 years of age: Do not use"],"effective_time":"20241219","id":"cfe109cb-2cbb-4929-84f6-5b4fe970e0c9","inactive_ingredient":["Inactive ingredients citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum"],"indications_and_usage":["Uses hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes 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 nasal congestion due to a cold"],"keep_out_of_reach_of_children":[""],"openfda":{"application_number":["M012"],"brand_name":["Tussnex FM Severe cough and congestion"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Guardian Drug Company"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["53041-617-58"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["53041-617"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1043543"],"spl_id":["cfe109cb-2cbb-4929-84f6-5b4fe970e0c9"],"spl_set_id":["387df403-7803-4031-915e-8de9b103a162"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0053041617584"]},"package_label_principal_display_panel":["PDP compare to the active ingredients in Mucinex Fast Max Severe Cough and congestion Maximum strength Tussnex FM Severe Cough and Congestion Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Phenylephrine HCl Nasal Decongestant Relieves: Soothes cough Thins and loosens mucus Relieves Nasal and chest congestion For ages 12 and over SN NM"],"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."],"purpose":["Purpose Cough suppressant Expectorant Nasal decongestant"],"set_id":"387df403-7803-4031-915e-8de9b103a162","spl_product_data_elements":["Tussnex FM Severe cough and congestion Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with 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."],"storage_and_handling":["Other information each 20 mL contains: sodium 20 mg store between 15-30 o C(59-86 o F) do not refrigerate dosing cup provided"],"version":"5","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 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with 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."],"when_using":["When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with 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."]}