{"active_ingredient":["Active Ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine Succinate 12.5 mg Antihistamine"],"active_ingredient_table":["
Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine Succinate 12.5 mgAntihistamine
"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquillizers if you are taking the blood thinning drug warfarin"],"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 take more than directed do not take more than 4 doses in any 24 hours 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 mL = mililiter TBSP = tablespoon dose as follows age dose adults and children 12 years of age and over 30 mL (2 Tablespoons) every 6 hours Children under 12 years of age do not use when using day time and night time prodcuts, carefully read each label to ensure correct dosing."],"dosage_and_administration_table":["
agedose
adults and children 12 years of age and over30 mL (2 Tablespoons) every 6 hours
Children under 12 years of agedo not use
"],"effective_time":"20241021","id":"24fec102-30d8-373f-e063-6394a90ac8ab","inactive_ingredient":["Inactive ingredients Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose"],"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"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Tukol Honey Nighttime Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA"],"package_ndc":["50066-303-04"],"product_ndc":["50066-303"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1043400"],"spl_id":["24fec102-30d8-373f-e063-6394a90ac8ab"],"spl_set_id":["bf25f38e-3549-4f78-be90-46605b5f2c11"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0650240051241"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton Night Time Tukol ® HONEY MULTISYMPTOM COLD & FLU Acetaminophen/ Dextromethorphan HBr / Doxylamine succinate Ages 12+ NATURAL HONEY FLAVOR Relieves: HEADACHE, SORE THROAT, FEVER MINOR ACHES AND PAINS SNEEZING, RUNNY NOSE COUGH 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 Ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine Succinate 12.5 mg Antihistamine"],"purpose_table":["
Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine Succinate 12.5 mgAntihistamine
"],"questions":["Questions or comments? 1-877-994-3666 Monday to Friday 8 am to 6 pm, Central Time"],"set_id":"bf25f38e-3549-4f78-be90-46605b5f2c11","spl_product_data_elements":["Tukol Honey Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 HONEY WATER GLYCERIN PROPYLENE GLYCOL SORBITOL SODIUM BENZOATE SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 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 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 18 mg store between 15-30 o C (59-86 o F) do not refrigerate"],"version":"9","warnings":["Warnings Liver warning The product contains Acetaminophen. Severe liver damage may occur if you take more than 4 doses (30 mL) 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 breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquillizers if you are taking the blood thinning drug warfarin When using this product do not use more than directed 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 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 serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product do not use more than directed 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"]}