{"active_ingredient":["Drug Facts Active Ingredient (in each dose cup 15 mL) Acetaminophen USP 325 mg Diphenhydramine HCl USP 12.5 mg Phenylephrine HCI USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma heart disease thyroid disease diabetes high blood pressure persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use to make a child sleepy if you are on a sodium-restricted diet 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 two 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. with any other product containing diphenhydramine, even one used on skin with any other acetaminophen containing products. This may lead to an overdose, which may cause liver damage. (see overdose warning )"],"dosage_and_administration":["Directions do not exceed recommended dosage (see overdose warning ) do not use in infants age dose adults and children 12 years and over 30 mL (2 dose cups) (1fl oz) every 4 hours children 4 years to under 12 years do not use unless directed by a doctor children under 4 years do not use Do not take more than 6 doses (12 dose cups) (180 mL) (6 fl oz) in 24 hours Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"100%\"><colgroup><col width=\"50%\"/><col width=\"50%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"top\"><content styleCode=\"bold\">age</content> </td><td styleCode=\"Rrule\" align=\"center\" valign=\"top\"><content styleCode=\"bold\">dose</content> </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\"> adults and children 12 years and over </td><td styleCode=\"Rrule\" valign=\"top\"> 30 mL (2 dose cups) (1fl oz) every 4 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\"> children 4 years to under 12 years </td><td styleCode=\"Rrule\" valign=\"top\"> do not use unless directed by a doctor </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\"> <content styleCode=\"bold\">children under 4 years</content> </td><td styleCode=\"Rrule\" valign=\"top\"><content styleCode=\"bold\"> do not use</content> </td></tr><tr><td styleCode=\"Lrule Rrule\" colspan=\"2\" valign=\"top\"> Do not take more than 6 doses (12 dose cups) (180 mL) (6 fl oz) in 24 hours </td></tr></tbody></table>"],"effective_time":"20201209","id":"10477221-f318-40f1-89ab-e488da358792","inactive_ingredient":["Inactive ingredients acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red # 40, flavor, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate Questions or comments? 1-855-274-4122 *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu ® . Failure to follow the drug facts warnings could result in serious consequences. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Distributed by: AUROHEALTH LLC. 2572 Brunswick Pike Lawrenceville, NJ 08648"],"inactive_ingredient_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"246.582\"><colgroup><col width=\"100%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"top\"><content styleCode=\"bold\">PARENTS:</content> <content styleCode=\"bold\">Learn about teen medicine abuse</content> </td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"top\"><content styleCode=\"bold\">www.StopMedicineAbuse.org</content> </td></tr></tbody></table>"],"indications_and_usage":["Uses temporarily relieves minor aches and pains sneezing headache minor sore throat pain nasal and sinus congestion cough due to minor throat and bronchial irritation runny nose itchy, watery eyes itchy nose or throat temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep this and all drugs out of the reach of children. Overdose Warning Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick 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":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8.3 FL OZ (245 mL Bottle) AUROHEALTH NDC 58602-140-33 AuroFlu Compare to the active ingredients in Theraflu ® Warming Relief Nighttime* Night Time Severe Cold & Cough Warming Relief Each dose (per 15 mL) of Syrup contains: 325 mg - ACETAMINOPHEN (Fever Reducer/Pain Reliever) 12.5 mg - DIPHENHYDRAMINE HCl (Cough Suppressant/Antihistamine) 5 mg - PHENYLEPHRINE HCl (Nasal Decongestant) Nasal congestion Runny Nose Cough Fever Body ache Sore throat Headache 8.3 FL OZ (245 mL) Cherry Flavor Alcohol Content: 10% PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8.3 FL OZ (245 mL Bottle)"],"purpose":["Purpose Fever Reducer/Pain Reliever Cough Suppressant/Antihistamine Nasal Decongestant"],"set_id":"524ef65d-08f9-45ab-8976-d88b5b56ce85","spl_product_data_elements":["AuroFlu Night Time Severe Cold and Cough Warming Relief Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 CHERRY GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM Red Colored Liquid"],"stop_use":["Stop use and ask a doctor if redness or swelling is present you get nervous, dizzy or sleepless pain, cough or nasal congestion gets worse or lasts more than7 days fever gets worse or lasts more than 3 days new symptoms occur sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting 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."],"storage_and_handling":["Other information sodium content per 15 mL: 7.09 mg potassium content per 15 mL: 4.66 mg store at 20-25 o C (68-77 o F) TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing see back panel for lot number and expiration date"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses (180 mL) in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. 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 use more than directed (see overdose warning ) 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"]}