{"active_ingredient":["Active ingredients (in each packet) Acetaminophen 650 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 5 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=\"92.44%\"><col width=\"53%\"/><col width=\"39%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"ordered\"><item><caption> </caption>Age</item></list></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><list listType=\"ordered\"><item><caption> </caption>Dose</item></list></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item><caption> </caption>adults and children</item><item><caption> </caption>12 years of age and over</item></list></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><list listType=\"ordered\"><item><caption> </caption>one packet</item></list></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><list listType=\"ordered\"><item><caption> </caption>children under</item><item><caption> </caption>12 years of age</item></list></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><list listType=\"ordered\"><item><caption> </caption>do not use</item></list></td></tr></tbody></table>"],"effective_time":"20240227","id":"77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, 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: o minor aches and pains o minor sore throat pain o headache o nasal and sinus congestion 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 Berry Burst"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0067-6800-02"],"product_ndc":["0067-6800"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1659967"],"spl_id":["77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9"],"spl_set_id":["ebbb2f4b-ba84-40ad-96f6-60225119a33b"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"]},"other_safety_information":["Other information • each packet contains : potassium 10 mg, sodium 20 mg • phenylketonurics : contains phenylalanine 14 mg per packet • store at controlled room temperature 20 - 25°C (68 - 77°F). Protect product from heat and moisture."],"package_label_principal_display_panel":["Principal Display Panel HALEON NDC 0067-6800-02 MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF DAYTIME FORMULA ACETAMINOPHEN Paint 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 Berry Burst Flavor 6 PACKETS Y:\\HAL-CH Drug Listing\\CH WORKING\\Theraflu Berry Burst 0067-6800\\Theraflu Severe Cold Relief Berry Burst 6 Packets.JPG"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/Fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or Comments? call 1-855-328-5259"],"set_id":"ebbb2f4b-ba84-40ad-96f6-60225119a33b","spl_product_data_elements":["Theraflu Severe Cold Relief Daytime Berry Burst Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM LECITHIN, SOYBEAN SUCROSE TRIBASIC CALCIUM PHOSPHATE Pink-purple Burst"],"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.com TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN 1-855-328-5259 Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2022 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. PA_620000000201493 HOT LIQUID THERAPY that relieves: Nasal and sinus congestion Cough Sore throat pain Headache Fever CARTON RECYCLE"],"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 last 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 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 last 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"]}