{"active_ingredient":["Active ingredients (in each tablet) Guaifenesin 400mg Dextromethorphan HBr 20mg"],"dosage_and_administration":["Directions take with a full glass of water do not exceed 6 doses in 24 hours adults and children 12 years of age and over take 1 tablet every 4 hours as needed children 6 to under 12 years of age take ½ tablet every 4 hours as needed children under 6 years of age consult a doctor"],"dosage_and_administration_table":["
adults and children 12 years of age and over
take 1 tablet every 4 hours as needed
children 6 to under 12 years of age
take ½ tablet every 4 hours as needed
children under 6 years of age
consult a doctor
"],"effective_time":"20251224","id":"fcbabd90-abc6-4a05-8841-58cb74b5a22e","inactive_ingredient":["Inactive ingredients magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid."],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make cough more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold"],"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."],"openfda":{"application_number":["M012"],"brand_name":["PHARBINEX-DM"],"generic_name":["GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG"],"is_original_packager":[true],"manufacturer_name":["Pharbest Pharmaceuticals, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["16103-381-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["16103-381"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1147685"],"spl_id":["fcbabd90-abc6-4a05-8841-58cb74b5a22e"],"spl_set_id":["8d71db43-da87-45ee-aa4a-7e870bc5016d"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","9D2RTI9KYH"]},"package_label_principal_display_panel":["PHARBEST NDC 16103-381-04 Manufactured in the USA Immediate Release PHARBINEX-DM *Compare to the active ingredient in MUCINEX ® DM Tablets Guaifenesin 400mg Dextromethorphan HBr 20mg Expectorant & Cough Suppressant 30 TABLETS Pharbinex DM Tablet Product Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant Cough suppressant"],"questions":["Questions? Adverse drug event call (866) 562-2756 Mon-Fri 8 AM to 4 PM"],"set_id":"8d71db43-da87-45ee-aa4a-7e870bc5016d","spl_product_data_elements":["PHARBINEX-DM GUAIFENESIN 400mg and DEXTROMETHORPHAN HBR 20MG GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID CAPSULE SHAPED TABLET PH073"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information store at room temperature (15°-30°C) Tamper Evident: do not use if safety seal under cap is broken or missing"],"version":"3","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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product. 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. Directions take with a full glass of water do not exceed 6 doses in 24 hours adults and children 12 years of age and over take 1 tablet every 4 hours as needed children 6 to under 12 years of age take ½ tablet every 4 hours as needed children under 6 years of age consult a doctor"],"warnings_table":["