Label: MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHTTIME COLD AND FLU- dextromethorphan hydrobromide, guaifenesin, acetaminophen,triprolidine hydrochloride kit

  • NDC Code(s): 72854-143-66, 72854-159-66, 72854-160-26
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 12, 2025

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

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active ingredients
    (in each 20 mL)
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Triprolidine HCl 2.5 mg

  • PURPOSE

    Dextromethorphan HBr » Cough Suppressant
    Guaifenesin » Expectorant

    Acetaminophen » Pain reliever/fever reducer
    Dextromethorphan » Cough suppressant
    Triprolidine HCl » Antihistamine

  • INDICATIONS & USAGE

    Uses


    ■ helps loosen phlegm (mucus) and thin
    bronchial secretions to rid the bronchial
    passageways of bothersome mucus and
    make coughs more productive
    ■ temporarily relieves:
    ■ 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

    ■ 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

    Do not use
    ■ 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
    ■ persistent or chronic cough such as occurs
    with smoking, asthma, chronic bronchitis, or
    emphysema
    ■ cough that occurs with too much phlegm (mucus)

    When using this product do not use more
    than directed


    Stop use and ask a doctor if
    ■ cough lasts more than 7 days, comes back, or
    occurs with fever, rash, or headache that lasts.
    These could be signs of a serious condition.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if
    you take:
    ■ more than 4,000 mg 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.
    ■ 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
    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 fever,
    rash, or headache that lasts. These
    could be signs of a serious condition.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ 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 of age and over:
    20 mL in dosing cup provided every 4 hours
    ■ children under 12 years of age: do not use

    Directions
    ■ do not take more than directed (see
    Overdose warning)
    ■ do not take more than 4 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 of age
    and over: 20 mL in dosing cup provided
    every 4 hours
    ■ children under 12 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 20 mL contains: sodium 9 mg
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

    Other information
    ■ each 20 mL contains: sodium 16 mg
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive ingredients

    ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow
    no. 10, edetate disodium, FD&C blue no. 1, flavor,
    glycerin (soy), propylene glycol, purified water,
    sodium benzoate, sorbitol, sucralose, trisodium
    citrate dihydrate*, xanthan gum
    *may contain this ingredient

    Inactive ingredients ammonium
    glycyrrhizate, anhydrous citric acid, edetate
    disodium, FD&C blue no. 1, FD&C red no.
    40, flavor, glycerin (soy), propylene glycol,
    purified water, sodium benzoate, sorbitol,
    sucralose, xanthan gum

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    carton label

    back label

  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHTTIME COLD AND FLU 
    dextromethorphan hydrobromide, guaifenesin, acetaminophen,triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-160
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-160-261 in 1 CARTON; Type 1: Convenience Kit of Co-Package04/02/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE 1 mL
    Part 20 BOTTLE
    Part 1 of 2
    MUCINEX FAST-MAX NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC:72854-143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-143-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/02/2025
    Part 2 of 2
    MUCINEX FAST-MAX KICKSTART SEVERE CONGESTION AND COUGH  MAXIMUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Item Code (Source)NDC:72854-159
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-159-66180 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/02/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/02/2025
    Labeler - RB Health (US) LLC (081049410)