AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]

AUROQUIL COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HBR) SOLUTION [AUROHEALTH LLC]
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NDC 58602-136-16, 58602-136-18, 58602-136-20
Set ID 74fb4ff2-0bda-4e76-b846-b33cba2e5cf0
Category Human OTC Drug Label
Packager Aurohealth LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • 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 38 mg
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, 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 58602-136-18

    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 58602-136-20

    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 58602-136-16

    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)

     

  • 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:58602-136
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CHERRY (UNII: BUC5I9595W)  
    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
    ColorREDScore    
    ShapeSize
    FlavorCHERRY, MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-136-18177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
    2NDC:58602-136-20237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
    3NDC:58602-136-16355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/27/201509/01/2021
    Labeler - Aurohealth LLC (078728447)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-136)

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