Label: MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH- acetaminophen, guaifenesin tablet, film coated

  • NDC Code(s): 72854-208-02, 72854-208-08, 72854-208-10, 72854-208-20
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 13, 2025

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

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplet)


    Acetaminophen 325 mg
    Guaifenesin 200 mg

  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves these common cold and flu
    symptoms:
    ■ minor aches and pains ■ headache
    ■ sore throat
    ■ helps loosen phlegm (mucus) and thin
    bronchial secretions to rid the bronchial
    passageways of bothersome mucus and make
    coughs more productive
    ■ temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:
    ■ more than 12 caplets in 24 hours, which is
    the maximum daily amount for this product
    ■ 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.


    Ask a doctor before use if you have
    ■ liver disease
    ■ 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
    ■ pain 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
    headache that lasts. These could be signs of
    a serious condition.


    If pregnant or breast-feeding, ask a health
    professional before use.

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ do not take more than directed (see
    Overdose warning)
    ■ do not take more than 12 caplets in any
    24-hour period
    ■ adults and children 12 years of age and
    over: take 2 caplets every 4 hours
    ■ children under 12 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information
    ■ store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    croscarmellose sodium, FD&C red no. 40
    aluminum lake, FD&C yellow no. 6 aluminum
    lake, magnesium stearate, microcrystalline
    cellulose, polyethylene glycol, polyvinyl
    alcohol, povidone, talc, titanium dioxide

  • QUESTIONS


    Questions? 1-866-MUCINEX
    (1-866-682-4639)

  • PURPOSE


    Acetaminophen 325 mg ........ Pain reliever/
    fever reducer
    Guaifenesin 200 mg.................... Expectorant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    carton label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH 
    acetaminophen, guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-208
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;MSC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-208-101 in 1 CARTON05/01/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:72854-208-202 in 1 CARTON05/01/2025
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:72854-208-022 in 1 POUCH; Type 0: Not a Combination Product05/01/2025
    4NDC:72854-208-084 in 1 CARTON05/01/2025
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Labeler - RB Health (US) LLC (081049410)