{"active_ingredient":["Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan HBr 20 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_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 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":["<table width=\"100%\"><col width=\"60%\"/><col width=\"40%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"ordered\"><item>Age</item></list></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"ordered\"><item>Dose</item></list></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item>adults and children</item><item>12 years of age and over</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item>one packet</item></list></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><list listType=\"ordered\"><item>children under</item><item>12 years of age</item></list></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><list listType=\"ordered\"><item>do not use</item></list></td></tr></tbody></table>"],"effective_time":"20240203","id":"107bff13-9a2b-6c45-e063-6294a90a95a2","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, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate"],"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"],"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, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-6802-02"],"product_ndc":["0067-6802"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1189316"],"spl_id":["107bff13-9a2b-6c45-e063-6294a90a95a2"],"spl_set_id":["7d902237-a990-4c5e-875b-291e124e143b"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["Principal Display Panel MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF DAYTIME FORMULA Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant Hot liquid therapy that relieves: Nasal and sinus congestion Cough Sore throat pain Headache Fever Honey Lemon Flavor 6 PACKETS 62000000201491 – Front Carton Theraflu Severe Cold Relief Daytime 6 packets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose s Pain reliever/Fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? call 1-855-328-5259"],"set_id":"7d902237-a990-4c5e-875b-291e124e143b","spl_product_data_elements":["THERAFLU Severe Cold Relief Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl 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 LECITHIN, SOYBEAN SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE LEMON FLAVOR"],"spl_unclassified_section":["Other information each packet contains: potassium 10 mg, sodium 19 mg phenylketonurics: contains phenylalanine 20 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.","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 ©2022 Haleon group of companies or its licensor. Trademarks are owned by or licensed to the Haleon group of companies."],"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":"1","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."],"when_using":["When using this product do not exceed recommended dosage"]}