Label: MUCINEX FAST-MAX LIQUID GELS DAY NIGHT COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate kit

  • NDC Code(s): 72854-168-10, 72854-168-24, 72854-168-48, 72854-171-08
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2026

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

  • SPL UNCLASSIFIED SECTION

  • PURPOSE

    Purpose Day:
    Acetaminophen 325 mg...Pain reliever/fever reducer

    Dextromethorphan HBr 10 mg.......Cough suppressant

    Purpose Night:

    Acetaminophen 325 mg...Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg.......Cough suppressant
    Doxylamine succinate 6.25 mg............. Antihistamine

  • ACTIVE INGREDIENT

    Day:

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Night:

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg

  • INDICATIONS & USAGE

    Day:

    ■ 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

    Night:

    ■ temporarily relieves these common cold and flu
    symptoms:
    ■ cough ■ minor aches and pains
    ■ sore throat ■ headache ■ runny nose
    ■ sneezing
    ■ itching of the nose or throat
    ■ itchy, watery eyes due to hay fever
    ■ temporarily reduces fever
    ■ controls cough to help you get to sleep

  • WARNINGS

    Day:


    Liver warning: This product contains
    acetaminophen. Severe liver damage may occur if
    you take:
    ■ more than 12 capsules 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.

    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.

    Night:


    Severe liver damage may occur if you take:
    ■ more than 12 capsules 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 ■ glaucoma
    ■ trouble urinating due to an enlarged prostate
    gland
    ■ a breathing problem such as emphysema or
    chronic bronchitis
    ■ 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
    ■ taking sedatives or tranquilizers


    When using this product
    ■ do not use more than directed
    ■ excitability may occur, especially in children
    ■ marked drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may
    increase drowsiness
    ■ avoid alcoholic drinks
    ■ use caution when driving a motor vehicle or
    operating machinery

  • DOSAGE & ADMINISTRATION

    Day:


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

    Night:

    Directions
    ■ do not take more than directed (see Overdose
    warning)
    ■ do not take more than 12 capsules in any 24-hour
    period
    ■ adults and children 12 years of age and over: take 2
    capsules 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)
    ■ avoid excessive heat

  • 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.

  • INACTIVE INGREDIENT

    Day:


    FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin,
    hypromellose, isopropyl alcohol, lecithin (sunflower),
    light mineral oil, mannitol, polyethylene glycol 400,
    povidone, propylene glycol, purified water, 1,4-sorbitan,
    sorbitol, titanium dioxide

    Night:


    D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin,
    hypromellose, isopropyl alcohol, lecithin (sunflower),
    light mineral oil, mannitol, polyethylene glycol 400,
    povidone, propylene glycol, purified water, 1,4-sorbitan,
    sorbitol, titanium dioxide

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    carton label

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX LIQUID GELS DAY NIGHT COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-168
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-168-101 in 1 CARTON06/01/2025
    11 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:72854-168-242 in 1 CARTON06/01/2025
    21 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NDC:72854-168-484 in 1 CARTON07/01/2026
    31 in 1 BLISTER PACK; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BLISTER PACK
    Part 20 BLISTER PACK
    Part 1 of 2
    MUCINEX FAST-MAX COLD AND FLU  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Item Code (Source)NDC:72854-171
    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 RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize24mm
    FlavorImprint Code AR18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-171-081 in 1 CARTON
    18 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Part 2 of 2
    MUCINEX FAST-MAX NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Item Code (Source)NDC:72854-003
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SORBITOL (UNII: 506T60A25R)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize24mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - RB Health (US) LLC (081049410)