{"active_ingredient":["Drug Facts"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet"],"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 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. to make a child sleep"],"dosage_and_administration":["Directions take only as directed – see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours mL = milliliter; TBSP = tablespoon adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing"],"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\" valign=\"top\">adults &amp; children 12 years &amp; over </td><td styleCode=\"Rrule\" valign=\"top\">30 mL (2 TBSP) every 4 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">children 4 to under 12 years </td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor </td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 4 years </td><td styleCode=\"Rrule\" valign=\"top\">do not use </td></tr></tbody></table>"],"effective_time":"20201116","id":"a75db285-ff85-4114-a279-932f37dd0d88","inactive_ingredient":["Inactive ingredients anhydrous citric acid, flavors, FD&C Blue no. 1, FD&C Red no. 40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (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":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle) AUROHEALTH Compare to the active ingredients in the Vicks ® NyQuil ® SEVERE Cold & Flu Relief Liquid * NDC 58602-148-20 Maximum Strength AuroQuil SEVERE COLD & FLU Nighttime Relief Each dose (per 30 mL) (2 TBSP) of oral solution contains: 650 mg - Acetaminophen USP (Pain reliever/fever reducer) 10 mg – Phenylephrine HCl USP (Nasal decongestant) 12.5 mg - Doxylamine succinate USP (Antihistamine) 20 mg - Dextromethorphan HBr USP (Cough suppressant) Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough Berry Flavor 8 FL OZ (237 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle) AUROHEALTH Compare to the active ingredients in the Vicks ® NyQuil ® SEVERE Cold & Flu Relief Liquid * NDC 58602-148-16 Maximum Strength AuroQuil SEVERE COLD & FLU Nighttime Relief Each dose (per 30 mL) (2 TBSP) of oral solution contains: 650 mg - Acetaminophen USP (Pain reliever/fever reducer) 10 mg – Phenylephrine HCl USP (Nasal decongestant) 12.5 mg - Doxylamine succinate USP (Antihistamine) 20 mg - Dextromethorphan HBr USP (Cough suppressant) Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough Berry Flavor 12 FL OZ (354 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 30 mL dose cup) Purpose Acetaminophen USP 650 mg .............................................. Pain reliever/fever reducer Dextromethorphan HBr USP 20 mg ............................................... Cough suppressant Doxylamine succinate USP 12.5 mg ........................................................ Antihistamine Phenylephrine HCl USP 10 mg ...................................................... Nasal decongestant"],"questions":["Questions or Comments? 1-855-274-4122 Distributed by: Aurohealth LLC. 2572 Brunswick Pike Lawrenceville, NJ 08648"],"set_id":"f77048ef-2a8b-4167-b033-984370e80d1e","spl_product_data_elements":["AuroQuil Severe Cold and Flu Nighttime Relief acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM Prosweet"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information each 30 mL dose cup contains: sodium 95 mg store at 20° to 25°C (68° to 77°F)"],"version":"4","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 use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness"]}