Label: NIGHTTIME COUGH- dextromethorphan hydrobromide and doxylamine succinate liquid 

  • Label RSS
  • NDC Code(s): 0363-0668-30, 0363-0668-38
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active ingredient (in each 15 mL tablespoon)

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

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  • Purpose

    Cough suppressant

    Antihistamine

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  • Uses

    temporarily relieves cold symptoms:

    cough
    runny nose and sneezing
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  • 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 sleepy

    Ask a doctor before use if you have

    glaucoma
    a breathing problem such as emphysema or chronic bronchitis
    cough that occurs with too much phlegm (mucus)
    trouble urinating due to an enlarged prostate gland
    persistent or chronic cough as occurs with smoking, asthma or emphysema

    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 for 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.

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  • Directions

    take only as recommended
    use dose cup
    do not exceed 4 doses per 24 hours

    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
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  • Other information

    each TBSP contains: sodium 15 mg
    store at 20°-25°C (68°-77°F)
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  • 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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to NyQuil® Cough active ingredients

    See Labeling Changes

    NightTime Cough

    All Night Cough Relief

    Cough Suppressant, Antihistamine

    Dextromethorphan HBr – Cough

    Doxylamine Succinate – Sneezing, Runny Nose

    Cherry Flavor

    10% Alcohol

    Nighttime Cough Label

    Nighttime Cough Label

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0668
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL
    DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    ANHYDROUS CITRIC ACID  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HIGH FRUCTOSE CORN SYRUP  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM CITRATE  
    Product Characteristics
    Color RED (Dark Red) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0668-30 177 mL in 1 BOTTLE
    2 NDC:0363-0668-38 296 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/16/2002
    Labeler - Walgreen Company (008965063)
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