Label: ADULT AUROTUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM - dextromethorphan hbr, doxylamine succinate liquid

  • 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 May 2, 2016

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

  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 30 mg
    Doxylamine Succinate, USP 12.5 mg

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  • Purposes

    Cough suppressant
    Antihistamine

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  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • controls the impulse to cough to help you sleep
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  • Warnings
  • Do not use

    • to sedate a child or to make a child sleepy
    • 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.
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  • Ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a 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
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  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

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  • When using this product

    • do not use more than directed
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
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  • Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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).

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  • Directions

    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • do not take more than 4 doses (8 tsp) in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    • shake well before using

    age
    dose
    adults and children 12 years and over
    10 mL every 6 hours
    children under 12 years
    do not use


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  • Other information

    • each 10 mL contains: sodium 7 mg
    • store at 20-25°C (68-77°F)
    • alcohol-free
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  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.

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  • Questions or Comments

    1-855-274-4122

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

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  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

    AUROHEALTH

    NDC 58602-159-24

    Compare to the active ingredients in
    Adult Robitussin
    ® Maximum Strength
    Nighttime Cough DM*

    ADULT
    Aurotussin
    MAXIMUM STRENGTH

    Nighttime Cough DM

    Each 10 mL dose of oral solution contains:
    30 mg - Dextromethorphan HBr, USP (Cough Suppressant)
    12.5 mg - Doxylamine Succinate, USP (Antihistamine)

    Relieves:

    Cough
    Itchy Throat
    Runny Nose
    Max Strength Nighttime Cough Control
    DM
    NIGHTTIME
    MAX

    Pineapple Flavor                                4 FL OZ
    For Ages 12 & Over                           (118 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL – 4FL OZ (118 mL Bottle)

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  • INGREDIENTS AND APPEARANCE
    ADULT AUROTUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM 
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-159
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 10 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ORANGE (UNII: 5EVU04N5QU)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color RED (a clear red colored liquid) Score     
    Shape Size
    Flavor MENTHOL, ORANGE, PINEAPPLE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58602-159-24 1 in 1 CARTON 05/02/2016
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 05/02/2016
    Labeler - Aurohealth LLC (078728447)
    Establishment
    Name Address ID/FEI Business Operations
    Aurohealth LLC 078728447 MANUFACTURE(58602-159)
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