{"active_ingredient":["Drug Facts Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis, or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use 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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"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 dose as follows age dose adults and children 12 years of age and older 20 mL every 4 hours children under 12 years of age do not use"],"dosage_and_administration_table":["
age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 12 years of age do not use
"],"effective_time":"20241016","id":"249cf9d5-787c-0364-e063-6394a90a6e67","inactive_ingredient":["Inactive Ingredients Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"],"indications_and_usage":["Uses temporarily relieves these common cold and flu symptoms: nasal congestion cough minor aches and pains sore throat headache temporarily reduces fever helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive"],"keep_out_of_reach_of_children":["Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Tukol MAX ACTION Cold, Sore Throat and Cough"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA, Inc"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50066-516-25"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50066-516"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1116572"],"spl_id":["249cf9d5-787c-0364-e063-6394a90a6e67"],"spl_set_id":["c8eebe64-00bf-436d-a9fc-1623401bebfa"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0650067000194"]},"other_safety_information":["Other information Each 20 mL contains: sodium 10 mg store between15-30°C (59-86 °F), do not refrigerate"],"package_label_principal_display_panel":["Tukol MAX ACTION Cold, Flu and Sore Throat Tukol® MAX ACTION DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING ACETAMINOPHEN/Dextromethorphan HBr/Guaifenesin/Phenylephrine HCl Relieves Minor aches and Pain Fever Nasal & Chest Congestion Cough Ages 12+ 6 FL OZ (177 mL) Distributed by: Genomma Lab USA, Inc. Houston, TX 77098 Tukol Max Cold"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding as a health professional before use"],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? 1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central time"],"set_id":"c8eebe64-00bf-436d-a9fc-1623401bebfa","spl_product_data_elements":["Tukol MAX ACTION Cold, Sore Throat and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough comes back or occurs with fever, rash or persistant headache fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur. These could be signs of a serious condition."],"version":"8","warnings":["Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and rash. If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly."],"when_using":["When using this product When using this product do not use more than directed"]}