Label: AUROQUIL COUGH NIGHTTIME COUGH RELIEF- dextromethorphan hbr and doxylamine succinate solution

  • NDC Code(s): 58602-132-16, 58602-132-18, 58602-132-20
  • 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 13, 2020

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  • 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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