{"active_ingredient":["Active ingredients (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 20mg Guaifenesin, 400 mg Phenylephrine HCl, 10 mg"],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period. • mL= milliliter age dose Adults and children 12 years of age and over 1 teaspoon (5 mL) every 4 hours Children under 12 years of age do not use"],"dosage_and_administration_table":["<table width=\"60%\" border=\"2\" cellspacing=\"2\" cellpadding=\"2\"><tbody><tr><td styleCode=\"Botrule Rrule Toprule\" align=\"center\">age</td><td styleCode=\"Botrule Toprule\" align=\"center\"> dose</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\" align=\"center\">Adults and children 12 years of age and over</td><td styleCode=\"Botrule Toprule\" align=\"center\"> 1 teaspoon (5 mL) every 4 hours</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\" align=\"center\">Children under 12 years of age</td><td styleCode=\"Botrule Toprule\" align=\"center\"> do not use</td></tr></tbody></table>"],"effective_time":"20251112","id":"e954ebb2-df25-40bf-b068-8ac861d6677b","inactive_ingredient":["Inactive ingredients artificial flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose."],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation"],"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":["TUSICOF"],"generic_name":["DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-239-01","52083-239-04","52083-239-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-239"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1091331"],"spl_id":["e954ebb2-df25-40bf-b068-8ac861d6677b"],"spl_set_id":["e966b75c-4bb4-4216-8247-baada8f5d759"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging TUSICOF"],"purpose":["Purposes 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 8AM to 4PM AST"],"recent_major_changes":["Directions: (The following changes were made) mL=milliliter A table was included with the dosage instructions according to age: age dose Adults and children 12 years of age and over 1 teaspoon (5mL) every 4 hours Children under 12 years of age do not use"],"recent_major_changes_table":["<table width=\"80%\"><caption/><tbody><tr><td>age</td><td>dose</td></tr><tr><td>Adults and children 12 years of age and over</td><td>1 teaspoon (5mL) every 4 hours</td></tr><tr><td>Children under 12 years of age</td><td><paragraph>do not use</paragraph></td></tr></tbody></table>"],"set_id":"e966b75c-4bb4-4216-8247-baada8f5d759","spl_product_data_elements":["TUSICOF dextromethorphan, guaifenesin, and phenylephrine DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN MENTHOL, UNSPECIFIED FORM METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Mint Flavor"],"spl_unclassified_section":["Drug Facts","Dextromethorphan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT Phenylephrine HCl NASAL DECONGESTANT SUGAR & ALCOHOL FREE NO SACCHARIN - NO SORBITOL NO ASPARTAME - NO DYE NO PHENYLPROPANOLAMINE Manufactured in USA with imported ingredients for Kramer Novis, San Juan, PR 00917. www.kramernovis.com"],"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 15-30°C (59-86°F) • Avoid excessive heat or humidity."],"version":"7","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 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."]}