Label: CVS MAXIMUM STRENGTH COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquid

  • NDC Code(s): 69842-903-06, 69842-903-09
  • 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 September 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Expectorant

    Phenylephrine HCl 10 mg

    Nasal decongestant
  • Uses

    ▪
    temporarily relieves these common cold and flu symptoms:
    ▪
    cough
    ▪
    nasal congestion
    ▪
    minor aches and pains
    ▪
    sore throat
    ▪
    sinus congestion and pressure
    ▪
    headache
    ▪
    temporarily reduces fever
    ▪
    temporarily promotes nasal and/or sinus drainage
    ▪
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning:

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

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

    Generic Section

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

    ▪
    skin
    ▪
    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

    ▪
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    ▪
    for children under 12 years of age
    ▪
    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

    ▪
    liver disease
    ▪
    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)

    Ask a doctor or pharmacist before use if

    ▪
    you are taking the blood thinning drug warfarin

    When using this product

    do not use more than directed

    Stop use and ask a doctor if

    ▪
    nervousness, dizziness, or sleeplessness occur
    ▪
    pain, nasal congestion, or cough 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 persistent headache.
    NaN
    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

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.

  • Directions

    ▪
    do not take more than directed (see Overdose Warning))
    ▪
    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
    ▪
    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 8 mg
    ▪
    store at room temperature
    ▪
    do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Cold, Flu

    NDC 69842-903-09

    Maximum Strength‡

    Cold, Flu &

    Relief

    Acetaminophen - Pain Reliever/Fever Reducer
    Dextromethorphan HBr - Cough Suppressant
    Guaifenesin - Expectorant
    Phenylephrine HCl - Nasal Decongestant

     
    ALL IN ONE*

    For Ages 12+

    9FL OZ (266mL)

    Principal Display Panel

    NDC 69842-903-06

    Maximum Strength ‡

    Cold & Flu Relief

    Acetaminophen - Pain Reliever/Fever Reducer
    Dextromethorphan HBr - Cough Suppressant
    Guaifenesin - Expectorant
    Phenylephrine HCl - Nasal Decongestant

    ALL IN ONE**

    •
    Headache
    •
    Body Pain
    •
    Sore Throat
    •
    Fever
    •
    Cough
    •
    Chest Congestion
    •
    Nasal congestion
    •
    Sinus Congestion
    •
    Sinus Pressure

    6 FL OZ (180 mL)

    For Ages 12+

    Do not use if printed seal under cap is broken or missing.

    Distributed by:

    *This product is not manufactured or distributed by RB Health, the distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu.

     Package Label for 9 FL OZ (266 mL)

    CVS Maximum Strength Mucus Relief Cold,Flu

    Package label for 6FL OZ (180 mL)

    CVS Maximum Strength Cold, Flu and sore throat 6 FL OZ 180mL
  • INGREDIENTS AND APPEARANCE
    CVS MAXIMUM STRENGTH COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-903
    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
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-903-09266 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/2021
    2NDC:69842-903-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/10/2021
    Labeler - CVS PHARMACY (062312574)
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