Label: DAYTIME COUGH NON DROWSY- dextromethorphan hydrobromide solution

  • NDC Code(s): 41250-473-38, 41250-473-40
  • 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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  • Active ingredient (in each 15 mL)

    Dextromethorphan HBr 15 mg

  • Purpose

    Cough suppressant

  • Use

    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
    •
    use dose cup
    •
    do not exceed 4 doses per 24 hours

    adults and children 12 years and over

    30 mL every 6-8 hours

    children 6 to under 12 years

    15 mL every 6-8 hours

    children 4 to under 6 years

    ask a doctor

    children under 4 years

    do not use
  • Other information

    •
    each 15 mL contains: sodium 13 mg
    •
    store at 20-25°C (68-77°F)
    •
    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

    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)

    473-6e-daytime-cough.jpg
  • INGREDIENTS AND APPEARANCE
    DAYTIME COUGH  NON DROWSY
    dextromethorphan hydrobromide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem 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:41250-473-38296 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/200707/13/2014
    2NDC:41250-473-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/15/2007
    Labeler - Meijer Distribution Inc (006959555)
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