Label: AUROQUIL COLD AND FLU NIGHTTIME RELIEF- acetaminophen, doxylamine succinate, and dextromethorphan hbr solution

  • NDC Code(s): 58602-137-16, 58602-137-18, 58602-137-20, 58602-137-35
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 28, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • PURPOSE

    Active ingredients (in each 30 mL dose cup)                   Purpose

    Acetaminophen, USP 650 mg                                       Pain reliever/fever reducer
    Dextromethorphan HBr, USP 30 mg                                       Cough suppressant
    Doxylamine succinate, USP 12.5 mg                                                Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
  • 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

  • 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
  • Ask a doctor before use if you have

    • liver disease
    • 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 a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin
  • 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
  • Stop use and ask a doctor if

    • pain 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.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose 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.

  • 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 6 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
  • Other information

    • each 30 mL dose cup contains: potassium 5 mg, sodium 37 mg
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or Comments?

    1-855-274-4122

    Distributed by:
    Aurohealth LLC.
    2572 Brunswick Pike,
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

    AUROHEALTH
    Compare to the active ingredients
    in Vicks® NyQuil® Cold & Flu*

    NDC 58602-137-18

    AuroQuil
    COLD & FLU
    Nighttime Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    650 mg - Acetaminophen USP (Pain reliever/fever reducer)
    12.5 mg - Doxylamine succinate USP (Antihistamine)
    30 mg - Dextromethorphan HBr USP (Cough suppressant)

    • Aches, Fever & Sore Throat
    • Sneezing, Runny Nose
    • Cough

    Alcohol 10%                         6 FL OZ (177 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

    AUROHEALTH
    Compare to the active ingredients
    in Vicks® NyQuil® Cold & Flu*

    NDC 58602-137-20

    AuroQuil
    COLD & FLU
    Nighttime Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    650 mg - Acetaminophen USP (Pain reliever/fever reducer)
    12.5 mg - Doxylamine succinate USP (Antihistamine)
    30 mg - Dextromethorphan HBr USP (Cough suppressant)

    • Aches, Fever & Sore Throat
    • Sneezing, Runny Nose
    • Cough

    Alcohol 10%                     8 FL OZ (237 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)

    AUROHEALTH
    Compare to the active ingredients
    in Vicks® NyQuil® Cold & Flu*

    NDC 58602-137-16

    AuroQuil
    COLD & FLU
    Nighttime Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    650 mg - Acetaminophen USP (Pain reliever/fever reducer)
    12.5 mg - Doxylamine succinate USP (Antihistamine)
    30 mg - Dextromethorphan HBr USP (Cough suppressant)


    • Aches, Fever & Sore Throat
    • Sneezing, Runny Nose
    • Cough

    Alcohol 10%                                     12 FL OZ (355 mL)

     PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL TWO 12 FL OZ (355 mL Bottles)

    VALUE
    Twin Pack

    AUROHEALTH
    Compare to the active ingredients
    in Vicks® NyQuil® Cold & Flu*


    NDC 58602-137-35

    AuroQuil
    COLD & FLU
    Nighttime Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    650 mg - Acetaminophen USP (Pain reliever/fever reducer)
    12.5 mg - Doxylamine succinate USP (Antihistamine)
    30 mg - Dextromethorphan HBr USP (Cough Suppressant)


    • Aches, Fever & Sore Throat
    • Sneezing, Runny Nose
    • Cough

     

    Alcohol 10%                                       Total 24 FL OZ (710 mL)

                                                                Two 12 FL OZ (355 mL) Bottles

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL TWO 12 FL OZ (355 mL Bottles)

  • INGREDIENTS AND APPEARANCE
    AUROQUIL COLD AND FLU NIGHTTIME RELIEF 
    acetaminophen, doxylamine succinate, and dextromethorphan hbr solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-137
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ANISE (UNII: 21C2F5E8RE)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorANISE, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-137-18177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2015
    2NDC:58602-137-20237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2015
    3NDC:58602-137-352 in 1 CARTON02/09/2015
    3NDC:58602-137-16355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/09/2015
    Labeler - Aurohealth LLC (078728447)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-137)