{"active_ingredient":["Active ingredient Acetaminophen, 650 mg Diphenhydramine hydrochloride, 25 mg Phenylephrine hydrochloride, 10 mg"],"ask_doctor":["Ask Doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • a sodium restricted diet • 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 the blood thinning drug warfarin"],"boxed_warning":["READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD."],"do_not_use":["Do not use • in a child under 4 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, as 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 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; do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink with 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=\"43%\"/> <col width=\"37%\"/> <tbody> <tr> <td align=\"center\" styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">Age</content> </paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">Dose</content> </paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">children under 4 years of age</content> </paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">do not use</content> </paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children 4 to under 12 years of age</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>do not use unless directed by a doctor </paragraph> </td> </tr> <tr> <td align=\"center\" styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>adults and children 12 years of age and over</paragraph> </td> <td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>one packet</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20170307","id":"0075197c-6d37-46ca-be07-38935b21cb80","inactive_ingredient":["Inactive ingredients acesulfame K, aspartame, citric acid, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, silicon dioxide, sodium citrate, 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 • 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":{},"package_label_principal_display_panel":["Principal Display Panel f705ff57-2dcb-4a1b-9871-9ab453852570-01"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Pain reliever / fever reducer Antihistamine / cough suppressant Nasal decongestant"],"questions":["Questions or Comments? call 1-800-452-0051"],"set_id":"f705ff57-2dcb-4a1b-9871-9ab453852570","spl_product_data_elements":["THERAFLU NIGHTTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ASPARTAME CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 HONEY LEMON MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE TRIBASIC CALCIUM PHOSPHATE"],"spl_unclassified_section":["Additional Information Listed On Other Panels Theraflu ® Nighttime Severe Cold & Cough ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT • Nasal Congestion • Cough • Runny Nose • Sneezing • Body Ache • Sore Throat Pain • Headache • Fever READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU ® PACKET IS TORN OR BROKEN. Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©20XX www.theraflu.com"],"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 • symptoms do not get better or worsen • 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. These could be signs of a serious condition."],"storage_and_handling":["Other information • each packet contains : potassium 10 mg, sodium 23 mg • phenylketonurics : contains phenylalanine 13 mg per packet • store at controlled room temperature 20-25°C (68-77°F). Protect from excessive heat and moisture."],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 packets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product 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 4 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, as 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 an MAOI, ask a doctor or pharmacist before taking this product. Ask Doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • a sodium restricted diet • 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 a doctor or pharmacist before use if you are taking • sedatives or tranquilizers the blood thinning drug warfarin 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 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 • symptoms do not get better or worsen • 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. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care 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 • 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"]}