{"active_ingredient":["Active ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine"],"active_ingredient_table":["<table width=\"75%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content> (in each 30 mL)</th><th>Purpose</th></tr></thead><tbody><tr><td><content styleCode=\"bold\">Acetaminophen 650 mg</content></td><td><content styleCode=\"bold\">Pain reliever/fever reducer</content></td></tr><tr><td>Dextromethorphan HBr 20 mg</td><td>Cough suppressant</td></tr><tr><td>Doxylamine succinate 12.5 mg</td><td>Antihistamine</td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to an enlarged prostate gland a sodium restricted diet"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin taking any other pain reliever or fever reducer."],"do_not_use":["Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 to make a child sleepy."],"dosage_and_administration":["Directions do not exceed 4 doses per 24 hours (see Overdose warning ). use the dosing cup provided and keep cup with product. mL = milliliter age dose adults & children 12 yrs & over 30 mL every 6 hrs children under 12 years of age do not use when using day time and night time products, carefully read each label to ensure correct dosing."],"dosage_and_administration_table":["<table width=\"75%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"center\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\" align=\"center\">age</th><th styleCode=\"Rrule\">dose</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Rrule\">30 mL every 6 hrs</td></tr><tr><td styleCode=\"Lrule Rrule\">children under 12 years of age</td><td styleCode=\"Rrule\">do not use</td></tr></tbody></table>"],"effective_time":"20260803","id":"d0742123-2ccf-4a19-901c-20b17db981f2","inactive_ingredient":["Inactive ingredients Citric acid, FD&C Blue # 1, FD&C red# 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, Sodium benzoate, sodium chloride, sorbitol, xanthan gum"],"indications_and_usage":["Uses temporarily relieves these common cold and flu symptoms: sore throat headache minor aches and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever relieves cough to help you sleep"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Tukol Max Action Cold and Flu Nighttime Relief"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA"],"package_ndc":["50066-520-06"],"product_ndc":["50066-520"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1042675"],"spl_id":["d0742123-2ccf-4a19-901c-20b17db981f2"],"spl_set_id":["cf0987a3-2c1d-4f40-8551-df9a8e08cd3d"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0650240082986"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton Acetaminophen / Dextromethorphan HBr / Doxylamine succinate Tukol ® MAX ACTION NIGHT SEVERE COLD & FLU Ages 12+ NIGHTTIME RELIEF RELIEVES COUGH FOR SLEEP Relieves: COUGH HEADACHE, SORE THROAT, FEVER MINOR ACHES AND PAINS SNEEZING & RUNNY NOSE 6 FL OZ (177 mL) PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine"],"purpose_table":["<table width=\"75%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content> (in each 30 mL)</th><th>Purpose</th></tr></thead><tbody><tr><td><content styleCode=\"bold\">Acetaminophen 650 mg</content></td><td><content styleCode=\"bold\">Pain reliever/fever reducer</content></td></tr><tr><td>Dextromethorphan HBr 20 mg</td><td>Cough suppressant</td></tr><tr><td>Doxylamine succinate 12.5 mg</td><td>Antihistamine</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":"cf0987a3-2c1d-4f40-8551-df9a8e08cd3d","spl_product_data_elements":["Tukol Max Action Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine Succinate Doxylamine Water Glycerin Propylene Glycol Sorbitol Sodium benzoate Saccharin sodium"],"spl_unclassified_section":["Drug Facts","Distributed by: Genomma Lab USA Inc., Houston, TX 77098"],"stop_use":["Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information each (30 mL) contains: sodium: 45 mg store at room temperature. Do not refrigerate."],"version":"1","warnings":["Warnings Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash. If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 to make a child sleepy. Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to an enlarged prostate gland a sodium restricted diet Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin taking any other pain reliever or fever reducer. When using this product avoid alcoholic drinks excitability may occur, especially in children marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness do not use more than directed. Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. 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. Overdose warning Taking more than the recommended dose may cause severe liver damage and other serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if there are no symptoms."],"when_using":["When using this product avoid alcoholic drinks excitability may occur, especially in children marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness do not use more than directed."]}