Label: COUGH RELIEF COUGH SUPPRESSANT- dextromethorphan hbr liquid

  • NDC Code(s): 63868-957-04
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredient (in each 5 mL)

    Dextromethorphan HBr 15 mg

  • Purpose

    Cough suppressant

  • Uses

    • temporarily relieves
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the impulse to cough to help you get to sleep
  • 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

    • chronic cough that lasts as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)

    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.

    When using this product

    • do not use more than directed

    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 (1-800-222-1222) right away.

  • Directions

    • take recommended dosage or as directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • shake well before using
    • mL = milliliter
    age dose
     adults and children 12 years and over 10 mL every 6-8 hours no to exceed 4 doses in 24 hours
     children 6 to 11 years of age 5 mL every 6-8 hours not to exceed 4 doses in 24 hours
     children under 6 years of age do not use

  • Other information

    • each 5 mL contains: sodium 3 mg
    • store between 20-25º C (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C yellow #6 flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COUGH RELIEF

    Cough Suppressant

    Dextromehtorphan HBr 15 mg

    Cough Suppressant

    For Ages 6 & Over

    6-8 Hour Relief

    Alcohol Free

    Orange Flavor

    FL OZ (mL)

    Contains no fever reducer or pain reliever

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    Distributed by C.D.M.A., Inc,©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

  • Package Label

    Dextromethorphan HBr 15 mg

    QUALITY CHOICE Cough Relief

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF  COUGH SUPPRESSANT
    dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-957
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-957-041 in 1 BOX07/31/2015
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/31/2015
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Registrant - P & L Development, LLC (079765031)
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