{"active_ingredient":["Active ingredients (in each packet) Acetaminophen, 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema, asthma 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 a pharmacist. ▪ with any other product containing diphenhydramine, even one used on the skin ▪ 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 a 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=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td align=\"center\" valign=\"top\" styleCode=\"Rrule Botrule Toprule \"><paragraph>Age</paragraph></td><td align=\"center\" valign=\"top\" styleCode=\"Botrule Lrule Toprule \"><paragraph>Dose</paragraph></td></tr><tr><td align=\"center\" valign=\"top\" styleCode=\"Rrule Botrule \"><paragraph>adults and children 12 years of age and over </paragraph></td><td align=\"center\" valign=\"top\" styleCode=\"Lrule Botrule \"><paragraph>one packet </paragraph></td></tr><tr><td align=\"center\" valign=\"top\" styleCode=\"Rrule Botrule \"><paragraph>children under 12 years of age</paragraph></td><td align=\"center\" valign=\"top\" styleCode=\"Botrule \"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20230713","id":"745934d0-9753-4473-9c08-e7904b1078b1","inactive_ingredient":["Inactive ingredients citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,"],"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 ▪ 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 at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["Principal Display Nighttime Severe Cold & Cough Honey Lemon Infused with Chamomile & White Tea Flavors 6 Packets"],"pregnancy_or_breast_feeding":["If pregnant or breast- feeding, ask a health care professional before use."],"purpose":["Purposes Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"745934d0-9753-4473-9c08-e7904b1078b1","spl_product_data_elements":["Nighttime Severe Cold and Cough ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE"],"spl_unclassified_section":["Additional Information Listed On Other Panels *Compare to the active ingredients in THERAFLU Nighttime Severe Cold &Cold* NDC 55319-451-06 NIGHTTIME SEVERE COLD & COUGH Acetaminophen – Pain Reliever/Fever Reducer Diphenhydramine HCl - Antihistamine/ Cough Suppressant Phenylephrine HCl – Nasal Decongestant Relieves • Cough • Nasal Congestion • Sore Throat Pain • Headache • Body Ache • Fever • Runny Nose • Sneezing 6 PACKETS Honey Lemon Infused with Chamomile and White Tea Flavors TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN OR BROKEN *This product is not manufactured or distributed by GSK consumer Healthcare, distributor of Theraflu Nighttime Severe Cold & Cough."],"spl_unclassified_section_table":["<table width=\"100%\"><col width=\"100%\"/><tbody><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph><content styleCode=\"bold\">TAMPER EVIDENT:</content> DO NOT USE INNER SEALED PACKET IF TORN OR BROKEN</paragraph></td></tr></tbody></table>"],"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 fever, rash or headache that lasts. There could be signs of a serious condition."],"storage_and_handling":["Other information ▪ each packet contains : potassium 6 mg ▪ Aspartame free, sodium free ▪ store at room temperature. Protect from excessive heat and moisture."],"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."],"when_using":["When using this product ▪ do not exceed recommended dosage ▪ 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"]}