{"active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg","Active ingredients (in each 30 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 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 or emphysema","Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin","Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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.","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. with any other product containing diphenhydramine, even one used on the skin 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 a MAO, 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","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":["
AgeDose
adults and children 12 years of age and over30 mL
children under 12 years of agedo not use
","
AgeDose
adults and children 12 years of age and over30 mL
children under 12 years of ageDo not use
"],"effective_time":"20240410","id":"15beba82-bd3d-a666-e063-6394a90a8867","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","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","Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever"],"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.","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 Daytime Nighttime Value Pack"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-8125-16","0067-8127-08","0067-8129-08"],"product_ndc":["0067-8125"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1113705","1298348","1803669"],"spl_id":["15beba82-bd3d-a666-e063-6394a90a8867"],"spl_set_id":["9736ad4c-8c2e-421f-b023-f91b72d2828b"]},"other_safety_information":["Other Safety Information DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2019 GSK group of companies or its licensor. 13440"],"package_label_principal_display_panel":["Principal Display Panel NDC 0067-8125-16 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache 8.3 FL OZ (245.5mL) Alcohol Free DAYTIME THERAFLU ExpressMax NIGHTTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache • Runny Nose 8.3 FL OZ (245.5mL) Alcohol Free NIGHTTIME 2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) Use Only As Directed 13440_Theraflu DT-NT Severe Cold & Cough Combo pack_2 bottles of 8.3 OZ.JPG","Principal Display Panel NDC 0067-8127-08 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache 8.3 FL OZ (245.5mL) Alcohol Free Theraflu ExpressMAX DT SCC.jpg","Principal Display Panel NDC 0067-8129-08 THERAFLU ExpressMax NIGHTTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Cough • Nasal Congestion • Sore Throat Pain • Fever • Headache • Body Ache • Runny Nose 8.3 FL OZ (245.5mL) Alcohol Free 13414_Theraflu ExpressMAX NT SCC_8.3 OZ.JPG.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant","Purposes Pain Reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant"],"questions":["Questions? call 1-800-328-5259","Questions? call 1-800-328-5259"],"set_id":"9736ad4c-8c2e-421f-b023-f91b72d2828b","spl_product_data_elements":["Theraflu ExpressMax Daytime Nighttime Value Pack Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Theraflu ExpressMax Daytime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl 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 WATER ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Theraflu ExpressMax Nighttime Severe Cold and Cough Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 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 WATER ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"spl_unclassified_section":["Other information each 30 mL contains : potassium 35 mg, sodium 17 mg store at controlled room temperature 20-25°C (68-77°F)","Theraflu ExpressMax Nighttime Severe Cold & Cough","Drug Facts","Other information each 30 mL contains : potassium 35 mg, sodium 17 mg store at controlled room temperature 20-25°C (68-77°F)"],"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.","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":"5","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 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.","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. with any other product containing diphenhydramine, even one used on the skin 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 a MAO, 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 glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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","When using this product do not exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}