Label: COUGH AND CONGESTION- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 51316-500-19
  • Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2025

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

  • Purpose

    Cough suppressant
    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs 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.

  • Directions

    • do not take more than directed
    • do not take more than 6 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
    • children under 12 years: do not use
  • Other information

    • each 20 mL contains: sodium 16 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal Display

    ♥CVSHealth®

    NDC 51316-500-19

    MAXIMUM STRENGTH
    COUGH &
    CONGESTION

    DEXTROMETHORPHAN HBr
    Cough Suppressant
    GUAIFENESIN
    Expectorant

    Oral Solution

    SYMPTOM RELIEF

    Controls cough

    Relieves chest
    congestion & mucus

    For Ages 12 & Over

    Compare to the active ingredients
    in Robitussin® Maximum Strength
    Cough + Chest Congestion DM†

    8 FL OZ
    (237 mL)

    Menthol-Berry Flavor

    ♥CVSHealth®

    You have quality
    standards. So do we.

    Keep your symptoms in
    check with quality products
    you can trust.

    With our CVS Health® brand,
    we perform ongoing tests
    and monitor customer
    feedback to help us exceed
    your expectations.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2024 CVS/pharmacy
    CVS.com®    1-800-SHOP CVS    V-19849

    ♥ 100% money back
    guaranteed.
    CVS.com/returnpolicy

    †This product is not manufactured or distributed by
    GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,
    owner of the registered trademark Robitussin®
    Maximum Strength Cough + Chest Congestion DM.

    50844 ORG012303019

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    CVS 44-030

    CVS 44-030

  • INGREDIENTS AND APPEARANCE
    COUGH AND CONGESTION 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorred (MAROON) Score    
    ShapeSize
    FlavorMENTHOL, BERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-500-191 in 1 CARTON04/08/2024
    1237 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 DrugM01204/08/2024
    Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(51316-500) , pack(51316-500)
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