{"active_ingredient":["Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan HBr 20 mg"],"ask_doctor":["Ask doctor before use if you have • liver disease • 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"],"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 a 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 • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat."],"dosage_and_administration_table":["
AgeDose
adults and children12 years of age and overone packet
children under 12 years of agedo not use
"],"effective_time":"20250505","id":"41da2cea-21f3-4162-b20d-ddbc66270b35","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no.10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate"],"indications_and_usage":["Uses • temporarily relieves these symptoms due to a cold: o minor aches and pains o minor sore throat pain o headache o 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 Daytime"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-0100-06","0067-0100-99"],"product_ndc":["0067-0100"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2670598"],"spl_id":["41da2cea-21f3-4162-b20d-ddbc66270b35"],"spl_set_id":["2b962d87-6ff5-4c0f-8504-e5b61c940612"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["362O9ITL9D","9D2RTI9KYH"]},"package_label_principal_display_panel":["Principal Display NEW FORMULA HALEON THERAFLU SEVERE COLD RELIEF Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant DAYTIME FORMULA Hot liquid therapy that relieves: / Cough / Sore throat pain / Head and body ache / Fever Honey Lemon Flavor 6 PACKETS Theraflu Severe Cold Relief Honey Lemon Daytime"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Cough suppressant"],"questions":["Questions or comments? 1-855-328-5259"],"set_id":"2b962d87-6ff5-4c0f-8504-e5b61c940612","spl_product_data_elements":["Theraflu Severe Cold Relief Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBr ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SOYBEAN LECITHIN SUCROSE TRIBASIC CALCIUM PHOSPHATE to off white, yellow and brown Lemon"],"spl_unclassified_section":["Additional information READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN 1-855-328-5259 Distributed by: Haleon, Warren, NJ 07059 ©2023 Haleon group of companies or its licensor. Trademarks are owned by or licensed to the Haleon group of companies. Pat. Info www.productpats.com 62000000207707"],"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, 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."],"storage_and_handling":["Other information • each packet contains: potassium 10 mg, sodium 20 mg • phenylketonurics: contains phenylalanine 20 mg per packet • store at controlled room temperature 20 o -25 o C (68 o - 77 o F). Protect product from heat and moisture."],"version":"3","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 a 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 doctor before use if you have • liver disease • 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 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, 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."]}