{"active_ingredient":["Active ingredients (in each chewable tablet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 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"],"dosage_and_administration":["Directions do not use more than directed do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist. Age Dose adults and children 12 years of age and over take 2 chewable tablets every 4 hours children under 12 years of age do not use"],"dosage_and_administration_table":["
AgeDose
adults and children 12 years of age and overtake 2 chewable tablets every 4 hours
children under 12 years of agedo not use
"],"effective_time":"20240905","id":"21636332-818b-26bf-e063-6394a90a1925","inactive_ingredient":["Inactive ingredients brown iron oxide, calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk"],"indications_and_usage":["Uses temporarily relieves these symptoms due to a cold: minor aches and pains 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 Soft Chews"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-0112-01"],"product_ndc":["0067-0112"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2691689"],"spl_id":["21636332-818b-26bf-e063-6394a90a1925"],"spl_set_id":["6ba64bbe-7599-406a-9187-737c0f8c1c2a"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NEW THERAFLU SEVERE COLD RELIEF NIGHTTIME Soft CHEWS Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant FAST relief ANYWHERE fever / cough / headache / body aches / sore throat / runny nose / sneezing / watery eyes 20 CHEWABLE TABLETS Chew tablets completely before swallowing Apple Cinnamon Flavor Theraflu SC Night Soft Chews 20 ct"],"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? call 1-855-328-5259"],"set_id":"6ba64bbe-7599-406a-9187-737c0f8c1c2a","spl_product_data_elements":["Theraflu Severe Cold Relief Nighttime Soft Chews Acetaminophen, Diphenhydramine HCl BROWN IRON OXIDE CALCIUM GLUCONATE MONOHYDRATE CARBOXYMETHYLCELLULOSE CALCIUM CARNAUBA WAX CORN SYRUP CROSPOVIDONE, UNSPECIFIED FD&C RED NO. 40 GLYCERIN MANNITOL STARCH, CORN SODIUM GLUCONATE SORBITOL SORBITOL SOLUTION SUCRALOSE SUCROSE COW MILK ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE N"],"spl_unclassified_section":["Other information each chewable tablet contains: calcium 10 mg, potassium 10 mg, sodium, 7 mg store at a controlled room temperature 20-25°C (68-77°F)","Generic Section Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken 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":"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. with any other product containing diphenhydramine, even one used on the skin 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"]}