{"active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease 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 to sedate a child or make a child sleepy"],"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":["
AgeDose
Adults and children 12 years of age and over30 mL
Children under 12 years of agedo not use
"],"effective_time":"20251113","id":"438014e3-6d78-1332-e063-6394a90afc47","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate"],"indications_and_usage":["Uses temporarily relieves these symptoms to a cold: minor aches and pains minor sore throat pain headache 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 Severe Cold Relief Nighttime"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-0105-08"],"product_ndc":["0067-0105"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1294607"],"spl_id":["438014e3-6d78-1332-e063-6394a90afc47"],"spl_set_id":["c24b9489-208c-472b-8ae5-c6e86c12e04d"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF NIGHTTIME Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant HELPS YOU REST* Powerful formula that relieves: / Cough / Sore throat pain / Head and body ache / Fever / Runny nose / Sneezing 8.3 FL OZ (245.5 mL) Berry Flavor *Temporarily controls cough to help you rest. This is not a sleep-aid. Theraflu Severe Cold Relief Nighttime 8.3 oz"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Antihistamine/Cough suppressant"],"questions":["Questions or comments? 1-855-328-5259"],"set_id":"c24b9489-208c-472b-8ae5-c6e86c12e04d","spl_product_data_elements":["Theraflu Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine HCl ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"],"spl_unclassified_section":["Other information each 30 mL contains: potassium 30 mg, sodium 13 mg store at controlled room temperature 20°-25°C (68° – 77°F)","Other Information Distributed by: Haleon, Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the Haleon group of companies. ©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com PEEL BACK HERE DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING."],"stop_use":["Stop use and ask a doctor if fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough 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":"4","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. with any other product containing diphenhydramine, even one used on the skin to sedate a child or make a child sleepy Ask a doctor before use if you have liver disease 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 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough 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 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"]}