Label: CVS MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 51316-740-04, 51316-740-08
  • Packager: CVS PHARMACY
  • 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 3, 2023

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

  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

  • Purposes

    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)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Stop use and ask a doctor if

    cough last for more than 7 days, comes back, 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

    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    keep dosing cup with product
    ml = milliliter
    this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

  • Other information

    each 20 mL contains: sodium 7 mg
    store at room temperature. Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C Red No. 40, flavor, menthol, microcrystalline cellulose, povidone, propylene glycol, purified water, potassium citrate, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    *Compare to the active ingredients of Robitussin® Cough + Chest Congestion DM*

    NDC# 51316-740-04

    MAXIMUM STRENGTH

    Adult

    Cough+Chest

    Congestion DM

    Dextromethorphan HBr (Cough Suppressant)

    Guaifenesin (Expectorant)

    Relieves Chest Congestion
    Controls cough
    Thins & Loosens Mucus

    Natural Raspberry Flavor

    For Ages 12 & Over

    4 FL OZ (118 mL)

    Distributed By:

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Cough + Congestion DM.

    Package Label For 4 FL OZ (118 mL)

    CVS Max Strength Dextrometorphan HBr, Guaifenesin

    Package Label For 8 FL OZ (237 mL)

    CVS Maximum Strength Adult Cough+Chest Congestion 8 FLoz 237 ml
  • INGREDIENTS AND APPEARANCE
    CVS  MAXIMUM STRENGTH
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-740
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-740-041 in 1 CARTON02/17/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51316-740-081 in 1 CARTON02/17/2023
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/17/2023
    Labeler - CVS PHARMACY (062312574)