{"active_ingredient":["Active Ingredient (in each 5 mL or 1 teaspoon) Purpose Dextromethorphan HBr, 10 mg Cough Suppressant Guaifenesin, 100 mg Expectorant Phenylephrine HCl, 5 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"100%\"><caption/><tbody><tr><td><content styleCode=\"bold\"> Active Ingredient (in each 5 mL or 1 teaspoon)</content></td><td><content styleCode=\"bold\"> Purpose</content></td></tr><tr><td> Dextromethorphan HBr, 10 mg</td><td> Cough Suppressant</td></tr><tr><td> Guaifenesin, 100 mg</td><td> Expectorant</td></tr><tr><td> Phenylephrine HCl, 5 mg</td><td> Nasal Decongestant </td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes 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"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant."],"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 6 doses in any 24 hour period This adult strength product is not intended for use in children under 12 years of age measure only with dosing cup provided keep dosing cup with product TSP = teaspoon age dose adults and children 12 years and over 2 teaspoons (10 ml) every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"55%\"><col width=\"50%\" align=\"center\" valign=\"middle\"/><col width=\"50%\" align=\"center\" valign=\"middle\"/><thead><tr styleCode=\"First Last\"><th align=\"center\" styleCode=\"Lrule Rrule\">age</th><th align=\"center\" styleCode=\"Rrule\">dose</th></tr></thead><tbody><tr styleCode=\"Botrule First\"><td align=\"center\" styleCode=\"Lrule Rrule\">adults and children 12 years and over</td><td align=\"center\" styleCode=\"Rrule\">2 teaspoons (10 ml) every 4 hours</td></tr><tr><td align=\"center\" styleCode=\"Lrule Rrule\">children under 12 years</td><td align=\"center\" styleCode=\"Rrule\">do not use</td></tr></tbody></table>"],"effective_time":"20241014","id":"247097cf-c927-d77a-e063-6394a90a5a19","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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 overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Tukol Cough and Congestion"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50066-510-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50066-510"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1044949"],"spl_id":["247097cf-c927-d77a-e063-6394a90a5a19"],"spl_set_id":["27ab3d86-e960-4d83-aad1-d50d2c8e02a9"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton Tukol ® MULTI-SYMPTOM COUGH & CONGESTION Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl Ages 12+ Relieves: COUGH NASAL CONGESTION CHEST CONGESTION 4 FL OZ (118 ml) Principal Display Panel - 118 ml Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active Ingredient (in each 5 mL or 1 teaspoon) Purpose Dextromethorphan HBr, 10 mg Cough Suppressant Guaifenesin, 100 mg Expectorant Phenylephrine HCl, 5 mg Nasal Decongestant"],"purpose_table":["<table width=\"100%\"><caption/><tbody><tr><td><content styleCode=\"bold\"> Active Ingredient (in each 5 mL or 1 teaspoon)</content></td><td><content styleCode=\"bold\"> Purpose</content></td></tr><tr><td> Dextromethorphan HBr, 10 mg</td><td> Cough Suppressant</td></tr><tr><td> Guaifenesin, 100 mg</td><td> Expectorant</td></tr><tr><td> Phenylephrine HCl, 5 mg</td><td> Nasal Decongestant </td></tr></tbody></table>"],"questions":["Questions or comments? 1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time."],"set_id":"27ab3d86-e960-4d83-aad1-d50d2c8e02a9","spl_product_data_elements":["Tukol Cough and Congestion Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"spl_unclassified_section":["Drug Facts","Distributed by: Genomma Lab USA Inc., Houston, TX 77027"],"stop_use":["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 persistant headache. These could be signs of a serious condition."],"storage_and_handling":["Other information each teaspoon (5 mL) contains: sodium 3 mg store at 15-30°C (59-86°F). Do not refrigerate."],"version":"53","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 heart disease high blood pressure thyroid disease diabetes 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 Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. Do not exceed recommended dosage. 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 persistant 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."]}