NITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [PUBLIX SUPER MARKETS INC]

NITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [PUBLIX SUPER MARKETS INC]
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NDC 56062-668-38, 56062-668-40
Set ID cae98e03-df0c-4eda-b0d7-22169d9ba66f
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves cold symptoms:

    cough due to minor throat and bronchial irritation
    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.

    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

    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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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

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

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • Other information

    each 30 mL contains: sodium 32 mg
    store at 20-25°C (68-77°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

  • Principal Display Panel

    nitetime

    DOXYLAMINE SUCCINATE

    DEXTROMETHORPHAN HBr

    COUGH SUPPRESSANT, ANTIHISTAMINE

    Cough

    Sneezing

    Runny nose

    CHERRY-FLAVORED LIQUID

    Compare to active ingredients in Vicks® NyQuil® Cough

    ALCOHOL 10%

    12 FL OZ (355 mL)

    668-63-nitetime.jpg
  • INGREDIENTS AND APPEARANCE
    NITETIME  COUGH
    dextromethorphan hydrobromide, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-668
    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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorRED (Dark Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-668-38296 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/200311/09/2013
    2NDC:56062-668-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/20/2003
    Labeler - Publix Super Markets Inc (006922009)

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