{"active_ingredient":["Active ingredient (in each soft gelatin capsule) Dextromethorphan HBr, USP 15 mg"],"ask_doctor":["Ask a doctor before use if you have 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 age dose adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use"],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">age</content></td><td><content styleCode=\"bold\">dose</content></td></tr><tr><td>adults and children 12 years and over</td><td>take 2 capsules every 6 to 8 hours, as needed</td></tr><tr><td>children under 12 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260427","id":"5003763c-806d-cd6b-e063-6294a90a374f","inactive_ingredient":["Inactive ingredients FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, purified water, sorbital sorbitan solution"],"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 Hydrobromide"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Pvt Ltd"],"package_ndc":["35916-0461-1","35916-0461-2","35916-0461-3","35916-0461-4"],"product_ndc":["35916-0461"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090487"],"spl_id":["5003763c-806d-cd6b-e063-6294a90a374f"],"spl_set_id":["20f7c1a9-fc4d-1f51-e063-6394a90a8be3"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"other_safety_information":["Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light"],"package_label_principal_display_panel":["bulk label label bulk label bul;k label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant"],"set_id":"20f7c1a9-fc4d-1f51-e063-6394a90a8be3","spl_product_data_elements":["Dextromethorphan Hydrobromide Dextromethorphan Hydrobromide GLYCERIN GELATIN, UNSPECIFIED FD&C RED NO. 40 PROPYL GALLATE WATER SORBITOL PROPYLENE GLYCOL POVIDONE K30 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLYETHYLENE GLYCOL 400 Transparent"],"spl_unclassified_section":["Manufactured By Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam , chengalpattu district, Tamilnadu - 603 103, India. Mfg. Lic. No.:XXXXXXXXXXXX"],"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."],"version":"5","warnings":["Warnings"]}