Label: MUCINEX FAST-MAX COLD AND FLU- acetaminophen, dextromethorphan hydrobromide tablet

  • NDC Code(s): 72854-161-02, 72854-161-04, 72854-161-10, 72854-161-20
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 2025

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Acetaminophen 325 mg...Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg...Cough suppressant

  • Uses

    Uses
    ■ temporarily relieves these common cold and flu
    symptoms:
    ■ cough due to minor throat and bronchial irritation
    as may occur with the common cold or inhaled
    irritants
    ■ the intensity of coughing
    ■ the impulse to cough to help you get to sleep
    ■ minor aches and pains
    ■ sore throat

    ■ headache
    ■ 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.
    ■ 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
    ■ persistent or chronic cough such as occurs with
    smoking, asthma, 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.

  • Directions

    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,
    microcrystalline cellulose, polyethylene glycol,
    polyvinyl alcohol, povidone, talc, titanium dioxide

  • QUESTIONS

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    Acetaminophen » Pain Reliever/Fever Reducer
    Dextromethorphan HBr » Cough Suppressant

  • PRINCIPAL DISPLAY PANEL

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code Chevron
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-161-101 in 1 CARTON04/01/2025
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:72854-161-202 in 1 CARTON04/01/2025
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:72854-161-022 in 1 POUCH; Type 0: Not a Combination Product04/01/2025
    4NDC:72854-161-042 in 1 CARTON04/01/2025
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2025
    Labeler - RB Health (US) LLC (081049410)