Label: MUCINEX FAST-MAX COLD, FLU AND SORE THROAT- acetaminophen, guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 20, 2026

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each caplet)

    Acetaminophen 325 mg
    Guaifenesin 200mg

  • PURPOSE

    Active ingredients Purposes
    (in each caplet)

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

  • 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

  • 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 older:
      take 2 caplets every 4 hours
    • children under 12 years of age: do not use
  • KEEP OUT OF REACH OF CHILDREN

    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.

  • 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

  • Other information

    • store at 20-25°C (68-77°F)
  • 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?

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

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US), Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

    full carton label

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX COLD, FLU AND SORE THROAT 
    acetaminophen, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code SC;Chevron
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-162-202 in 1 CARTON04/01/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2025
    Labeler - Reckitt Benckiser LLC (094405024)