AUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]

AUROQUIL COUGH NIGHTTIME COUGH RELIEF (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) SOLUTION [AUROHEALTH LLC]
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NDC 58602-132-16, 58602-132-18, 58602-132-20
Set ID 3fd3c799-1ae4-406d-9371-00a531fbe585
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
     Dextromethorphan HBr USP 30 mg ............................................. Cough suppressant
    Doxylamine succinate USP 12.5 mg .............................................. Antihistamine

  • Uses

    temporarily relieves cold symptoms:

    • cough
    • runny nose and sneezing
  • Warnings

  • Do not use

    • 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

    • glaucoma
    • excessive 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.

  • 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

    • cough lasts more than 7 days, 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 professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
    • mL = milliliter; TBSP = tablespoon
    adults and children 12 years and 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: sodium 35 mg
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, 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® Cough*

    NDC 58602-132-20

    AuroQuil
    COUGH
    Nighttime Cough Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    30 mg - Dextromethorphan HBr USP (Cough suppressant)
    12.5 mg - Doxylamine succinate USP (Antihistamine)


    • Cough
    • Sneezing, Runny Nose

    Alcohol 10%                           Cherry Flavor                        6 FL OZ (177 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

    AUROHEALTH

    Compare to the active ingredients
    in Vicks® NyQuil® Cough*

    NDC 58602-132-18

    AuroQuil
    COUGH
    Nighttime Cough Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    30 mg - Dextromethorphan HBr USP (Cough suppressant)
    12.5 mg - Doxylamine succinate USP (Antihistamine)


    • Cough
    • Sneezing, Runny Nose

    Alcohol 10%                           Cherry Flavor                        8 FL OZ (236 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

    AUROHEALTH

    Compare to the active ingredients
    in Vicks® NyQuil® Cough*

    NDC 58602-132-16

    AuroQuil
    COUGH
    Nighttime Cough Relief

    Each dose (per 30 mL) (2 TBSP) of oral solution contains:
    30 mg - Dextromethorphan HBr USP (Cough suppressant)
    12.5 mg - Doxylamine succinate USP (Antihistamine)


    • Cough
    • Sneezing, Runny Nose

    Cherry Flavor

    Alcohol 10%
                                         12 FL OZ  (354 mL)

                                                                           
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    AUROQUIL COUGH NIGHTTIME COUGH RELIEF 
    dextromethorphan hbr and doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    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)  
    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
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-132-20177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
    2NDC:58602-132-18236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/201509/01/2021
    3NDC:58602-132-16354 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(58602-132)

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