{"active_ingredient":["Active ingredient (in each softgel) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 200 mg"],"ask_doctor":["Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"do_not_use":["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."],"dosage_and_administration":["Directions • do not take more than 12 softgels in any 24-hour period • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 softgels every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["
agedose
adults and children 12 years and over2 softgels every 4 hours
children under 12 yearsdo not use
"],"effective_time":"20241125","id":"27c8006d-0566-29d6-e063-6394a90a7054","inactive_ingredient":["Inactive ingredients FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"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":["Maximum Strength-Cough and Chest Congestion DM"],"generic_name":["MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["53345-034-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["53345-034"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1111663"],"spl_id":["27c8006d-0566-29d6-e063-6394a90a7054"],"spl_set_id":["d1830989-fe82-4f08-8618-78979fcef568"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules Quantity : 4000 Capsules NDC. No : 53345-034-01 IMPORTANT: Inspect immediately upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. Store at 15-30°C (59-86°F) CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Cough Chest Congestion DM Bulk Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant Expectorant"],"set_id":"d1830989-fe82-4f08-8618-78979fcef568","spl_product_data_elements":["Maximum Strength-Cough and Chest Congestion DM Maximum Strength-Cough and Chest Congestion DM FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL SORBITOL WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN OBLONG PC37"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information • store at room temperature 15-30°C (59-86°F) • avoid excessive heat above 40°C (104°F)"],"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 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) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for 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 overdose, get medical help or contact a Poison Control Center right away."]}