Label: COUGH- dextromethorphan hbr solution

  • 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 March 31, 2016

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

  • Active ingredient (in each 15 mL)

    Dextromethorphan HBr 15 mg

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  • Purpose

    Cough suppressant

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  • Use

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

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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.

    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).

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  • 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

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  • 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
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  • 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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    COMPARE TO the Active Ingredient of Vicks® DayQuil® Cough

    Non-Drowsy

    Cough

    Dextromethorphan HBr – Cough Suppressant

    Daytime

    All Day Cough Relief Up to 8 Hours

    Cough

    Alcohol Free

    Antihistamine Free

    Citrus Blend Flavor

    12 FL OZ (355 mL)

    HyVee Health Cough image
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  • INGREDIENTS AND APPEARANCE
    COUGH 
    dextromethorphan hbr solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-500
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color ORANGE (light) Score     
    Shape Size
    Flavor CITRUS (blend) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-500-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 02/12/2014
    Labeler - HyVee Inc (006925671)
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