{"active_ingredient":["Active Ingredient (in each 5 mL or 1 teaspoon) Purpose Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, 50 mg Expectorant Phenylephrine HCl, 2.5 mg Nasal Decongestant"],"active_ingredient_table":["
Active Ingredient (in each 5 mL or 1 teaspoon) Purpose
Dextromethorphan HBr, 5 mg Cough Suppressant
Guaifenesin, 50 mg Expectorant
Phenylephrine HCl, 2.5 mg Nasal Decongestant
"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema 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 take more than 6 doses in any 24 hour period measure only with dosing cup provided keep dosing cup with product TSP = teaspoon age dose children 6 to under 12 years 2 teaspoons (10 mL) every 4 hours children 4 to under 6 years 1 teaspoon (5 mL) every 4 hours children under 4 years do not use"],"dosage_and_administration_table":["
agedose
children 6 to under 12 years2 teaspoons (10 mL) every 4 hours
children 4 to under 6 years1 teaspoon (5 mL) every 4 hours
children under 4 yearsdo not use
"],"effective_time":"20241011","id":"2439cdd1-e22d-530e-e063-6394a90ab78e","inactive_ingredient":["Inactive ingredients citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, 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 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":["50066-308-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50066-308"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1370205"],"spl_id":["2439cdd1-e22d-530e-e063-6394a90ab78e"],"spl_set_id":["235a6d2b-7302-410c-be35-4d5ff7bbdfce"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton Tukol ® Children's COUGH & CONGESTION Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl Ages 4+ Relieves: COUGH NASAL CONGESTION CHEST CONGESTION 4 FL OZ (118 ml) Principal Display Panel - 118 ml Bottle Carton"],"purpose":["Active Ingredient (in each 5 mL or 1 teaspoon) Purpose Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, 50 mg Expectorant Phenylephrine HCl, 2.5 mg Nasal Decongestant"],"purpose_table":["
Active Ingredient (in each 5 mL or 1 teaspoon) Purpose
Dextromethorphan HBr, 5 mg Cough Suppressant
Guaifenesin, 50 mg Expectorant
Phenylephrine HCl, 2.5 mg Nasal Decongestant
"],"questions":["Questions or comments? 1-877-994-3666"],"set_id":"235a6d2b-7302-410c-be35-4d5ff7bbdfce","spl_product_data_elements":["Tukol Children Cough and Congestion Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"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 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":"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 high blood pressure thyroid disease diabetes cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema 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 persistant 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."]}