Label: NITETIME COUGH DAYTIME COUGH- dextromethorphan hydrobromide, doxylamine succinate kit

  • NDC Code(s): 41250-031-02, 41250-473-40, 41250-668-40
  • Packager: Meijer Distribution Inc
  • 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 3, 2021

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  • Nighttime CoughActive 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 #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    1-800-719-9260

  • Daytime CoughActive ingredient (in each 15 mL)

    Dextromethorphan HBr 15 mg

  • Purpose

    Cough suppressant

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

  • 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

    •
    cough that occurs with too much phlegm (mucus)
    •
    persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • 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 6-8 hrs

    children 6 to under 12 yrs

    15 mL every 6-8 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 15 mL contains: sodium 13 mg
    •
    store at 20-25°C (68-77F)
    •
    does not meet USP requirements for light resistant packaging
  • Inactive ingredients

    anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel – NiteTime Cough

    COMBO PACK

    Compare to Vicks® NyQuil® Cough active ingredients

    nitetime cough

    Dextromethorphan HBr

    Cough Suppressant

    Doxylamine Succinate | Antihistamine

    All Night Cough Relief

    Cherry Flavor

    ALCOHOL 10%

    Relieves: Cough, Sneezing, Runny Nose

    12 FL OZ (355 mL)

  • Principal Display Panel – DayTime Cough

    COMBO PACK

    Compare to Vicks® DayQuil® Cough active ingredient

    NON-DROWSY

    daytime cough

    Dextromethorphan HBr

    Cough Suppressant

    All Day Cough Relief

    Citrus Blend Flavor

    Alcohol Free

    Antihistamine Free

    Powerful Cough Relief for up to 8 hours

    12 FL OZ (355 mL)

    031-6e-daytime-nitetime.jpg
  • INGREDIENTS AND APPEARANCE
    NITETIME COUGH DAYTIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-031
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-031-021 in 1 KIT; Type 0: Not a Combination Product02/13/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 355 mL
    Part 21 BOTTLE 355 mL
    Part 1 of 2
    NITETIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:41250-668
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorRED (Dark Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-668-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/03/2003
    Part 2 of 2
    DAYTIME COUGH  NON DROWSY
    dextromethorphan hydrobromide solution
    Product Information
    Item Code (Source)NDC:41250-473
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorORANGE (light) Score    
    ShapeSize
    FlavorCITRUS (blend) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-473-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/15/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/13/2013
    Labeler - Meijer Distribution Inc (006959555)
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