{"active_ingredient":["Active ingredients (in each 30 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 trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"],"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 in a child under 12 years of age if you are allergic to acetaminophen 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, 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."],"dosage_and_administration":["Directions do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"72%\"/><col width=\"28%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"ordered\"><item>Age</item></list></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"ordered\"><item>Dose</item></list></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item>adults and children 12 years of age and over</item></list></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item>30 mL</item></list></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><list listType=\"ordered\"><item>children under 12 years of age</item></list></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><list listType=\"ordered\"><item>do not use</item></list></td></tr></tbody></table>"],"effective_time":"20240307","id":"131940e0-559f-0aa1-e063-6394a90a779f","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"],"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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Theraflu ExpressMax Severe Cold and Flu Syrup"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["0067-8132-08"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["0067-8132"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1369842"],"spl_id":["131940e0-559f-0aa1-e063-6394a90a779f"],"spl_set_id":["777d2ac7-e3cc-4513-8b6f-b90b2ff2c672"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"other_safety_information":["Other information each 30 mL contains : potassium 30 mg, sodium 14 mg store at controlled room temperature 20-25°C (68-77°F)"],"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 0067-8132-08 Theraflu ® Expressmax ™ SEVERE COLD AND FLU ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT GUAIFENESIN- EXPECTORANT PHENYLEPHRINE HCl- NASAL DECONGESTANT BODY ACHE FEVER CHEST CONGESTION NASAL CONGESTION HEADACHE COUGH SORE THROAT PAIN ALCOHOL FREE BERRY FLAVOR 8.3 FL OZ (245.5 mL) PARENTS : Learn about teen medicine abuse www.StopMedicineAbuse.org *Maximum Strength per 4 hour dose. Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 Trademarks are owned or licensed to the GSK group of companies. © 2016 GSK group of companies or its licensor. All rights reserved. 12265_Theraflu expressmax severe cold and flu syrup.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or Comments? call 1-855-328-5259"],"set_id":"777d2ac7-e3cc-4513-8b6f-b90b2ff2c672","spl_product_data_elements":["Theraflu ExpressMax Severe Cold and Flu Syrup Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl WATER ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 a 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 in a child under 12 years of age if you are allergic to acetaminophen 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, 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 you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 exceed recommended dosage"]}