{"active_ingredient":["Active ingredient (in each softgel) Dextromethorphan HBr, USP 15 mg"],"ask_doctor":["Ask a doctor before use if the user has a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, 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 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years of age and over take 2 capsules every 6 to 8 hours, as needed children under 12 years of age do not use"],"dosage_and_administration_table":["<table border=\"1\"><tbody><tr><td><paragraph>adults and children 12 years of age and over</paragraph></td><td><paragraph> take 2 capsules every 6 to 8 hours, as needed</paragraph></td></tr><tr><td><paragraph>children under 12 years of age</paragraph></td><td><paragraph> do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20241121","id":"2767cee1-e298-26d6-e063-6294a90ab8b8","inactive_ingredient":["Inactive ingredients FD&C blue #1, 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) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a 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":["Dextromethorphan HBr 15 mg"],"generic_name":["DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."],"package_ndc":["53345-011-01"],"product_ndc":["53345-011"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090487"],"spl_id":["2767cee1-e298-26d6-e063-6294a90ab8b8"],"spl_set_id":["028b025e-2dde-4bef-ba7b-61774e855b4b"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label Dextromethorphan HBr Capsules, 15 mg Quantity : 12000 Capsules NDC No. : 53345-011-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" Shipping Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant"],"questions":["Questions or comments? Call toll free 1-855-215-8180"],"set_id":"028b025e-2dde-4bef-ba7b-61774e855b4b","spl_product_data_elements":["Dextromethorphan HBr 15 mg Dextromethorphan HBr FD&C RED NO. 40 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE WATER PROPYLENE GLYCOL SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CLEAR OVAL PC6"],"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 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light"],"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 the user has a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, 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."]}