Label: NIGHTTIME COUGH- dextromethorphan hydrobromide and doxylamine succinate liquid

  • NDC Code(s): 42507-668-30, 42507-668-34, 42507-668-38
  • Packager: HyVee Inc
  • 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 12/12

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

  • Active ingredients (in each 30 mL dose cup)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

    Close
  • Purpose

    Cough suppressant

    Antihistamine

    Close
  • Uses

    temporarily relieves cold symptoms

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

    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
    may cause marked drowsiness
    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)

    Close
  • Directions

    take only as directed
    use dose cup
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL (2 TBSP) every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
    Close
  • Other information

    each 30 mL dose cup contains: sodium 32 mg
    store at 20°-25°C (68°-77°F)
    Close
  • 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

    Close
  • Questions or comments?

    1-800-719-9260

    Close
  • Principal Display Panel

    Compare to Vicks® NyQuil® Cough active ingredients

    Night Time

    Cough

    Cherry Flavor

    All Night Cough Relief

    Dextromethorphan HBr – Cough

    Doxylamine succinate – Sneezing, Runny Nose

    10% ALCOHOL

    Cough Suppressant, Antihistamine

    Night Time Cough Label Image 1
    Night Time Cough Label Image 2
    Close
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-668
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 12.5 mg  in 30 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 Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-668-30 177 mL in 1 BOTTLE
    2 NDC:42507-668-34 237 mL in 1 BOTTLE
    3 NDC:42507-668-38 296 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/20/2003
    Labeler - HyVee Inc (006925671)
    Close