Label: CVS SEVERE TUSSIN CF MAX- acetaminophen, 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 June 29, 2022

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

  • Active ingredients (in each 20 mL)

    Acetaminophen, USP 650 mg

    Dextromethorphan HBr, USP 20 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

  • Uses

    temporarily relieves these symptoms occurring with a cold or flu:
    cough due to minor throat and bronchial irritation
    minor aches and pains
    sore throat
    headache
    temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    more than 6 doses in any 24 hours period, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    skin reddening
    blisters
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • 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.
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • Ask a doctor before use if you have

    liver disease
    cough that occurs with too much phlegm (mucus)
    a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema
  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin
    Taking any other pain reliever/fever reducer
  • When using this product do not use more than directed.

  • Stop use and ask a doctor if

    pain, cough, or nasal congestion gets worse or lasts more than 7 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    new symptoms occur
    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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    do not take more than 6 doses in any 24-hour period
    do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
    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 13 mg
    store at room temperature Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red #40, glycerin, menthol, flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare to active ingredients in Robitussin® Maximum Strength Severe Cough + Sore Throat*

    NDC# 69842-947-08

    MAXIMUM STRENGTH

    Non–Drowsy

    Severe Tussin CF Max

    ACETAMINOPHEN

    Pain reliever / Fever reducer

    DEXTROMETHORPHAN HBr

    Cough Suppressant

    Adult Cough & Sore Throat

    Relieves:

    Cough
    Sore throat pain

    For Ages 12 Years & older

    Dosage cup provided

    Actual Product Size on Side Panel

    8 FL OZ (237 mL)

    *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin Maximum Strength Severe Cough + Sore Throat.

    Maximum Strength claim based on maximum levels of active ingredients per dose.

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2019 CVS/pharmacy

    CVS.com

    1-800-SHOP CVS

    V-12431

    CVS Quality

    Money Back Guarantee

    CVS Health Max Strength Acetaminophen, Dextromethorphan HBr
  • INGREDIENTS AND APPEARANCE
    CVS SEVERE TUSSIN CF MAX 
    acetaminophen, dextromethorphan hbr solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-947
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-947-081 in 1 CARTON04/15/2019
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/15/2019
    Labeler - CVS PHARMACY (062312574)