{"active_ingredient":["Active Ingredients (in each 5 mL tsp) Dextromethorphan HBr, 10 mg Guaifenesin, 187 mg"],"dosage_and_administration":["Directions Take every 4 hours, or as directed by a doctor. Direc"],"effective_time":"20251114","id":"73a7e53a-91e6-4f2a-98f0-d73ba7995194","inactive_ingredient":["Inactive ingredients Citric acid, flavors, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose."],"indications_and_usage":["Uses • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive."],"keep_out_of_reach_of_children":["Keep out of reach of children . In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["PECGEN DMX"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["KRAMER NOVIS"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-630-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-630"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1441364"],"spl_id":["73a7e53a-91e6-4f2a-98f0-d73ba7995194"],"spl_set_id":["a627824c-5e3d-4672-a047-6c801b50b432"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0352083630163"]},"package_label_principal_display_panel":["Packaging Pecgen-1"],"purpose":["Purposes Antitussive Expectorant"],"questions":["Questions or comments? Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 . San Juan, PR 00917 www.kramernovis.com"],"set_id":"a627824c-5e3d-4672-a047-6c801b50b432","spl_product_data_elements":["PECGEN DMX Dextromethorphan HBr, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE MENTHOL, UNSPECIFIED FORM METHYLPARABEN POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE"],"spl_unclassified_section":["Drug Facts","Contains the same active ingredients as Trispec® DMX* Sugar, Alcohol, Dye and Gluten FREE CHERRY RASPBERRY FLAVOR Manufactured in the USA for Kramer Novis *Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp."],"storage_and_handling":["Other information • Store at controlled room temperature 15°-30°C (59°-86°F). • Avoid excessive heat or humidity. • Tamper Evident Feature: Do not use if inner seal is torn, broken or missing."],"version":"5","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 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 • cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. When using this product, do not use more than directed. Stop use and ask a doctor if • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, 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 accidental overdose, get medical help or contact a Poison Control Center right away."]}