Label: CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

  • 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 September 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 20 mL)    		Purposes

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant

    Phenylephrine HCl 10 mg

    Nasal decongestant
  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    •
    temporarily relieves:
    •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    •
    the intensity of coughing
    •
    nasal congestion due to a cold
    •
    temporarily helps you cough less
  • 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

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    trouble urinating due to an enlarged prostate gland
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    •
    cough that occurs with too much phlegm (mucus)

    When using this product do not use more than directed

    Stop use and ask a doctor if

    •
    nervousness, dizziness or sleeplessness occur
    •
    symptoms do not get better within 7 days or occur with fever
    •
    cough comes back, or occurs with rash or headache that lasts. 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 at (1-800-222-1222).

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    do not use dosing cup with other products
    •
    dose as follows or as directed by a doctor
    •
    mL = milliliter
    •
    adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours.
    •
    children under 12 years of age: Do not use.
  • Other information

    •
    each 20 mL contains: sodium 6 mg
    •
    very low sodium
    •
    store at room temperature
    •
    do not refrigerate
    •
    dosing cup provided

    Inactive Ingredients

    anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC# 69842-767-06

    Compare to Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough Clear and Cool® Active Ingredients*

    Maximum Strength

    Severe Congestion & Cough

     

    Dextromethorphan HBr Cough Suppressant
    Guaifenesin Expectorant
    Phenylephrine HCl Nasal Decongestant

    Cooling Menthol Flavor

    Naturally and Artificially Flavored

    6 FL OZ (180 mL)

    For Ages 12+

    Tamper evident: do not use if printed seal under cap is broken or missing.

    Distributed by:

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast -Max® Maximum Strength Severe Congestion & Cough Clear & Cool™.

    CVS Maximum Strength Severe Congestion & cough
  • INGREDIENTS AND APPEARANCE
    CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-767
    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
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propyl gallate (UNII: 8D4SNN7V92)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMENTHOL (Cooling Menthol) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-767-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/2020
    Labeler - CVS PHARMACY, INC (062312574)
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