Label: MAXIMUM STRENGTH MUCUS RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 83324-143-06
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 13, 2025

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

  • ACTIVE INGREDIENTS (in each 20 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCI 10 mg 

  • PURPOSE

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • USE(S)

    temporarily relieves these common cold and flu symptoms:

    • sore throat
    • nasal congestion
    • minor aches and pains
    • headache
    • cough due to minor throat and bronchial irritation
    • sinus congestion and pressure
    • temporarily reduces fever
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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

    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

    • 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

    • diabetes
    • high blood pressure
    • thyroid disease
    • 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 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, fever 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

    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. Quick 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 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 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 15 mg
    • store between 15-30ºC (59-86ºF)
    • do not refrigerate
    • dosing cup provided

  • INACTIVE INGREDIENTS

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

  • PRINCIPAL DISPLAY PANEL

    NDC 83324-143-06

    QC® QUALITY CHOICE

     

    *Compare to the Active Ingredients in Maximum Strength Mucinex® Fax Max™ Cold, Flu & Sore Throat

     

    Maximum Strength Mucus Relief 

    Cold, Flu & Sore Throat


    Acetaminophen

    Pain Reliever & Fever Reducer

    Dextromethorphan HBr  

     Cough Suppressant
    Guaifenesin  

     Expectorant
    Phenylephrine HCI 

     Nasal Decongestant

     

    For Ages 12+


    6 FL OZ (177 mL)


     

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCUS RELIEF 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-143
    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
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    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
    ColorBLUEScore    
    ShapeSize
    FlavorBERRY (mixed berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-143-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/13/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/13/2025
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(83324-143)