{"active_ingredient":["Active ingredients DRUG FACTS Active ingredients (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 50 mg Phenylephrine HCL, USP 2.5 mg"],"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."],"dosage_and_administration":["Directions age dose children 6 to 12 years 2 tsp (10 mL) every 4 hours children 4 to 6 years 1 tsp (5 mL) every 4 hours children under 4 years do not use do not exceed 6 doses in a 24-hour period use enclosed dosage cup tsp = teaspoon, mL = milliliter"],"effective_time":"20171228","id":"158e568c-c1da-4e77-a6a4-34062f86f1fc","inactive_ingredient":["Inactive ingredients citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"],"indications_and_usage":["Uses help 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 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":["part341"],"brand_name":["Tukol A"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50066-536-24"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50066-536"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1370205"],"spl_id":["158e568c-c1da-4e77-a6a4-34062f86f1fc"],"spl_set_id":["651f0d7c-c76b-434d-95fd-427609b40b46"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0650066000539"]},"other_safety_information":["Other information each 5 mL contains: sodium 3 mg store at room temperature"],"package_label_principal_display_panel":["Children's Tukol Bottle Label Children’s Tuko l ® Cough Suppressant/Expectorant/Nasal Decongestant Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI Ages 4+ Cough and Cold Gets rid of phlegm Quiets Cough Clears nasal congestion Grape Flavor 4 FL OZ (118 ml) Drug Facts Active in gredients Purpose (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 5 mg ...............Cough suppressant Guaifenesin, 50 mg. .......................................Expectorant Phenylephrine HCI, 2.5 mg ................... Nasal decongestant 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 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 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. When using this product • do not use more than directed 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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. Drug Facts (continued) Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Directions • do not exceed 6 doses in a 24-hour period • use enclosed dosage cup • tsp = teaspoon, mL = milliliter age dose children 6 to 12 years 2 teaspoons (10 mL) every 4 hours children 4 to 6 years 1 teaspoons (5 mL) every 4 hours children under 4 years do not use Other information • each 5 mL contains: sodium 3 mg • store at room temperature Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum Questions or comments? 1-877-99 GENOM (43666) Distributed by Genomma Lab USA., Houston, TX, 77027 TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. LR-063 Rev. 2 PEEL HERE Tukol-BTL-037-RV2","Children's Tukol Box Label Children’s Tukol ® Cough Suppressant/Expectorant/Nasal Decongestant Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Children’s Tukol ® Cough Suppressant/Expectorant/Nasal Decongestant Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI Ages 4+ Cough and Cold Gets rid of phlegm Quiets Cough Clears nasal congestion Grape Flavor 4 FL OZ (118 ml) LOT No. Exp. Drug Facts Active ingredients Purpose (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 5 mg ...............Cough suppressant Guaifenesin, 50 mg. .......................................Expectorant Phenylephrine HCI, 2.5 mg ................... Nasal decongestant 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 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 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. When using this product • do not use more than directed 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 last 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. Distributed by Genomma Lab USA Inc., Houston, TX 77027 Genomma Lab. ® 3 66975-3 8/17 Drug Facts (continued) Directions • do not exceed 6 doses in a 24-hour period • use enclosed dosage cup • tsp = teaspoon, mL = milliliter age dose children 6 to 12 years 2 teaspoons (10 mL) every 4 hours children 4 to 6 years 1 teaspoons (5 mL) every 4 hours children under 4 years do not use Other information • each 5 mL contains: sodium 3 mg • store at room temperature Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum Questions or comments? 1-877-99 GENOM (43666) BX-037 Rev. 02 2FTAP1MUEWW1B Tukol-BX-037-RV2"],"purpose":["Purpose Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? 1 877 99 GENOM (43666)"],"set_id":"651f0d7c-c76b-434d-95fd-427609b40b46","spl_product_data_elements":["Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM GRAPE FLAVOR"],"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 a 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."],"version":"4","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."],"when_using":["When using this product do not use more than directed"]}