{"dosage_and_administration":[""],"effective_time":"20251002","id":"402896d4-831f-c53d-e063-6294a90a21b3","inactive_ingredient":["Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder"],"indications_and_usage":["cough cold, allergic"],"keep_out_of_reach_of_children":["KEEP OUT OF THE REACH OF CHILDREN"],"openfda":{"application_number":["M012"],"brand_name":["Guaifenesin and Dextromethorphan Hydrobromide"],"generic_name":["GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["InvaTech Pharma Solutions LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["57631-013-10"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["57631-013"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1147685"],"spl_id":["402896d4-831f-c53d-e063-6294a90a21b3"],"spl_set_id":["40288ecf-043d-eb9e-e063-6394a90ac0a7"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","9D2RTI9KYH"]},"package_label_principal_display_panel":["Label"],"purpose":["FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"],"set_id":"40288ecf-043d-eb9e-e063-6394a90ac0a7","spl_product_data_elements":["Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide MAGNESIUM STEARATE MALTODEXTRIN POVIDONE K30 HYPROMELLOSES SODIUM STARCH GLYCOLATE TYPE A POLYETHYLENE GLYCOL 400 MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM SILICON DIOXIDE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ET16"],"version":"4","warnings":["KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"]}