{"active_ingredient":["Active ingredients (in each 2.5 mL) Purpose Dextromethorphan HBr, 5 mg Cough suppressant Guaifenesin, 50 mg Expectorant Phenylephrine HCl, 2.5 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each 2.5 mL)Purpose
Dextromethorphan HBr, 5 mgCough suppressant
Guaifenesin, 50 mgExpectorant
Phenylephrine HCl, 2.5 mgNasal decongestant
"],"ask_doctor":["Ask a doctor before use if the child has heart disease diabetes high blood pressure thyroid disease cough that lasts or is chronic such as occurs with asthma cough that occurs with too much phlegm (mucus)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant."],"do_not_use":["Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions do not exceed 6 doses in a 24-hour period measure only with dosing cup provided keep dosing cup with product mL = mililiter age dose children 6 to under 12 years 5 mL every 4 hours children 4 to under 6 years 2.5 mL every 4 hours children under 4 years do not use"],"dosage_and_administration_table":["
agedose
children 6 to under 12 years5 mL every 4 hours
children 4 to under 6 years2.5 mL every 4 hours
children under 4 yearsdo not use
"],"effective_time":"20241018","id":"24c1f740-5460-0dad-e063-6394a90a8fa0","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"],"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 (1-800-222-1222) immediately."],"openfda":{"application_number":["M012"],"brand_name":["Tukol Honey Children 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":["50066-301-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50066-301"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1044949"],"spl_id":["24c1f740-5460-0dad-e063-6394a90a8fa0"],"spl_set_id":["dae33df8-2294-4242-a25b-2d89d1f63b23"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0650240051258"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton Tukol ® HONEY CHILDREN COUGH & CONGESTION Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl Ages 4+ NATURAL HONEY FLAVOR Relieves: COUGH NASAL CONGESTION CHEST CONGESTION 4 FL OZ (118 ml) PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton"],"purpose":["Active ingredients (in each 2.5 mL) Purpose Dextromethorphan HBr, 5 mg Cough suppressant Guaifenesin, 50 mg Expectorant Phenylephrine HCl, 2.5 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each 2.5 mL)Purpose
Dextromethorphan HBr, 5 mgCough suppressant
Guaifenesin, 50 mgExpectorant
Phenylephrine HCl, 2.5 mgNasal decongestant
"],"questions":["Questions or comments? 1-877-994-3666"],"set_id":"dae33df8-2294-4242-a25b-2d89d1f63b23","spl_product_data_elements":["Tukol Honey Children Cough and Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 HONEY SODIUM BENZOATE WATER GLYCERIN PROPYLENE GLYCOL SORBITOL XANTHAN GUM SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Amber to yellow"],"spl_unclassified_section":["Drug Facts","Distributed by: Genomma Lab USA Inc., Houston, TX 77098"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs 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."],"storage_and_handling":["Other information each 2.5 mL contains: sodium 1 mg store at 15-30ºC (59-86ºF). Do not refrigerate."],"version":"6","warnings":["Warnings Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child has heart disease diabetes high blood pressure thyroid disease cough that lasts or is chronic such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant. Do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately."],"when_using":["Do not exceed recommended dosage."]}