Label: MUCINEX RAPID CLEAR DAY NIGHT AND CLEAR AND COOL NASAL- acetaminophen, guaifenesin, dextromethorphan hydrobromide, triprolidine hydrochloride, and oxymetazoline hydrochloride kit

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

Drug Label Information

Updated June 18, 2025

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

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    DAY

    Acetaminophen 325 mg
    Guaifenesin 200 mg

    NIGHT

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Triprolidine HCl 1.25 mg

    SPRAY

    Oxymetazoline hydrochloride 0.05%

  • PURPOSE

    DAY

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

    NIGHT

    Acetaminophen 325 mg ........ Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg................Cough suppressant
    Triprolidine HCl 1.25 mg...................................Antihistamine

    SPRAY

    Oxymetazoline hydrochloride 0.05% - Nasal decongestant

  • INDICATIONS & USAGE

    DAY

    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

    NIGHT

    Uses
    ■ 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

    SPRAY

    Uses

    temporarily relieves nasal congestion due to:

    • a cold
    • hay fever or other upper respiratory allergies
    • promotes nasal and sinus drainage
    • temporarily relieves sinus congestion and pressure
    • helps clear nasal passages; shrinks swollen membranes

  • WARNINGS

    DAY

    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.

    NIGHT

    Warnings
    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if you take:
    ■ more than 8 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 ■ 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 amotor vehicle or operatingmachinery
    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.

    SPRAY

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    difficulty in urination due to enlargement of the prostate gland

    When using this product

    do not exceed recommended dosage
    do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
    this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
    the use of this container by more than one person may spread infection

    Stop use and ask a doctor ifsymptoms persist

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

  • DOSAGE & ADMINISTRATION

    DAY

    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

    NIGHT

    Directions
    ■ do not take more than directed (see Overdose warning)
    ■ do not take more than 8 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

    SPRAY

    adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    children under 6 years of age: consult a doctor.

    Shake well before use.


    To open, hold by the white grips then squeeze, push down
    firmly and turn cap counterclockwise. Before using for the
    first time, remove the protective cap from the tip and prime
    metered pump by depressing firmly several times. To spray,
    hold bottle with thumb at the base and nozzle between first
    and second fingers. Without tilting head, insert nozzle into
    nostril. Fully depress pump all the way down with a firm
    even stroke and sniff deeply. Wipe nozzle clean after use.
    To close, turn cap clockwise.
    DO NOT DISCARD CAP.

  • OTHER SAFETY INFORMATION

    DAY/NIGHT/SPRAY

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

  • INACTIVE INGREDIENT

    DAY

    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

    NIGHT

    Inactive ingredients
    croscarmellose sodium, crospovidone, hypromellose,
    microcrystalline cellulose, polyethylene glycol,
    polysorbate 80, povidone, titanium dioxide

    SPRAY

    benzalkonium chloride,
    benzododecinium chloride,
    camphor

  • QUESTIONS

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • PRINCIPAL DISPLAY PANEL

    carton label

    back label

    full carton label

  • INGREDIENTS AND APPEARANCE
    MUCINEX RAPID CLEAR DAY NIGHT AND CLEAR AND COOL NASAL 
    acetaminophen, guaifenesin, dextromethorphan hydrobromide, triprolidine hydrochloride, and oxymetazoline hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-213
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-213-031 in 1 CARTON06/01/2025
    11 in 1 KIT; Type 1: Convenience Kit of Co-Package
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK
    Part 30 BOTTLE, PUMP 1 mL
    Part 1 of 3
    MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH 
    acetaminophen, guaifenesin tablet, film coated
    Product Information
    Item 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
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;MSC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Part 2 of 3
    MUCINEX NIGHTSHIFT SINUS  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride tablet, coated
    Product Information
    Item Code (Source)NDC:72854-209
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code VVV;LOGOcrescentmoonplus
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2025
    Part 3 of 3
    MUCINEX SINUS-MAX  SEVERE NASAL CONGESTION RELIEF CLEAR AND COOL NASAL
    oxymetazoline hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-129
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    122 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2025
    Labeler - RB Health (US) LLC (081049410)