{"active_ingredient":["Active ingredients (in each 5 mL 1 teaspoonful) Dextromethorphan HBr 20 mg Guaifenesin 388 mg Phenylephrine HCl 10 mg"],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period • mL = milliliter, tsp = teaspoon adults and children 12 years of age and over 5 mL (1 teaspoon) every 4 hours children under 12 years of age do not use"],"dosage_and_administration_table":["<table width=\"50%\"><caption/><tbody><tr><td styleCode=\"Botrule Rrule Toprule\">adults and children 12 years of age and over</td><td styleCode=\"Lrule Toprule Botrule\">5 mL (1 teaspoon) every 4 hours</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\">children under 12 years of age</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20251203","id":"2d816a62-defd-4fa4-8809-73fb009e0394","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium citrate, sucralose"],"indications_and_usage":["Uses • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves nasal congestion due to 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":["TUSSLIN"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-624-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-624"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2728493"],"spl_id":["2d816a62-defd-4fa4-8809-73fb009e0394"],"spl_set_id":["987e19a5-032f-44e9-b4c7-8a764d502695"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging TUSSLIN"],"purpose":["Purpose Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? 1-787-767-2072 You may also report serious side effects to this phone number . Call weekdays from 8:00 am to 4:00 pm AST"],"set_id":"987e19a5-032f-44e9-b4c7-8a764d502695","spl_product_data_elements":["TUSSLIN Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE"],"spl_unclassified_section":["Drug Facts","Sugar, Alcohol, and Dye FREE Manufactured for Kramer Novis, San Juan, PR 00917 www.kramernovis.com Made in USA with imported ingredients"],"storage_and_handling":["Other information • tamper evident feature: do not use if printed security seal is torn, broken or missing. • store at controlled room temperature 15-30ºC (59-86ºF) • avoid excessive heat or humidity."],"version":"1","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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • 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 • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • 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."]}