{"active_ingredient":["Active ingredient Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg"],"ask_doctor":["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 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. 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 an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions do not use more than directed adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor children under 12 years of age: do not use"],"effective_time":"20240307","id":"13185fea-1e12-cf5a-e063-6394a90a18af","inactive_ingredient":["Inactive ingredients benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide"],"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 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."],"openfda":{"application_number":["M012"],"brand_name":["Theraflu ExpressMax Nighttime Severe Cold and Cough"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-8137-20","0067-8137-10"],"product_ndc":["0067-8137"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1233575"],"spl_id":["13185fea-1e12-cf5a-e063-6394a90a18af"],"spl_set_id":["62f7fcb9-e31a-4634-b1c2-44a9567e3a61"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40","04JA59TNSJ"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0067-8137-20 Theraflu ® Express Max ® NIGHTTIME SEVERE COLD & COUGH WARMING RELIEF™ FORMULA ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT PEHNYLEPHRINE HCl – NASAL DECONGESTANT NASAL CONGESTION • SORE THROAT • FEVER • BODY ACHE RUNNY NOSE • HEADACHE • COUGH • SNEEZING 20 COATED CAPLETS *Maximum Strength per 4 hour dose. TAMPER EVIDENT FEATURE: THERAFLU ® EXPRESSMAX ® CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN. READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies or its licensor. All rights reserved. 62000000010602 62000000010602_Theraflu Expressmax Nighttime SCC caplets_20 ct.JPG"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant"],"questions":["Questions or comments? call 1-800-452-0051"],"set_id":"62f7fcb9-e31a-4634-b1c2-44a9567e3a61","spl_product_data_elements":["Theraflu ExpressMax Nighttime Severe Cold and Cough acetaminophen, diphenhydramine HCl, phenylephrine HCl BENZOIC ACID CROSCARMELLOSE SODIUM ALCOHOL FD&C BLUE NO. 2 ALUMINUM OXIDE FERROSOFERRIC OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 60 POLYSORBATE 80 POVIDONE, UNSPECIFIED STARCH, CORN PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID SUCRALOSE TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE caplet 1143N"],"spl_unclassified_section":["Other information 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."],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe lever 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 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 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 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"]}