Label: MUCINEX-SINUS MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL AND MUCINEX NIGHTSHIFT SINUS CLEAR AND COOL- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride kit

  • NDC Code(s): 63824-116-66, 63824-267-66, 63824-270-66
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 24, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Mucinex Sinus-Max
    SEVERE CONGESTION & PAIN CLEAR & COOL
    Acetaminophen 650mg.......... ................Pain reliever
    Guaifenesin 400 mg.................................Expectorant
    Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

    Mucinex Nightshift
    Sinus Clear & Cool
    Acetaminophen 650mg..........Pain reliever/fever reducer
    Dextromethorphan HBr 20 mg..............Cough suppressant
    Phenylephrine HCl 10mg. . . . . . . . . . . . . . .. . .Nasal decongestant
    Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . .Antihistamine

  • Uses

    Mucinex Sinus-Max SEVERE CONGESTION & PAIN
    CLEAR & COOL
    temporarily relieves:
    ■ nasal congestion

    ■ headache

    ■ minor aches and pains
    ■ sinus congestion and pressure
    ■ temporarily promotes nasal and/or sinus drainage
    ■ helps loosen phlegm (mucus) and thin bronchial secretions to
    rid the bronchial passageways of bothersome mucus and
    make coughs more productive

    Mucinex Nightshift Sinus Clear & Cool
    temporarily relieves these common cold and flu symptoms:
    ■ cough

    ■ nasal congestion

    ■ minor aches and pains
    ■ sore throat

    ■ headache
    ■ sinus congestion and pressure

    ■ 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

    Warnings
    Liver warning: This product contains acetaminophen. Severe liver
    damage may occur if you take:


    ■ more than 4000 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 (Nightshift Sinus Clear & Cool only):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

    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 ■ heart disease ■ diabetes
    ■ high blood pressure
    ■ thyroid disease
    ■ glaucoma (Nightshift Sinus Clear & Cool only)
    ■ trouble urinating due to an enlarged prostate gland
    ■ a breathing problem such as emphysema or chronic bronchitis
    (Nightshift Sinus Clear & Cool only)
    ■ 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
    ■ taking sedatives or tranquilizers (Nightshift Sinus Clear & Cool only)

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

    Stop use and ask a doctor if
    ■ nervousness, dizziness, or sleeplessness occur
    ■ pain, nasal congestion, 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.

    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.

  • Directions

    MUCINEX SINUS-MAX SEVERE CONGESTION & PAIN
    CLEAR & COOL

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


    MUCINEX NIGHTSHIFT SINUS CLEAR & COOL
    ■ 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

    ■ each 20 mL contains: sodium
    9mg (Severe Congestion & Pain
    Clear & Cool only) and sodium
    16mg (Nightshift Sinus Clear &
    Cool only)
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

  • INACTIVE INGREDIENT

    (Mucinex Sinus-Max
    Severe Congestion & Pain
    Clear & Cool)

    anhydrous citric
    acid, D&C yellow no. 10, edetate
    disodium, FD&C blue no. 1,
    flavors, glycerin, propyl gallate,
    propylene glycol, purified water,
    sodium benzoate, sorbitol,
    sucralose, trisodium citrate
    dihydrate*, xanthan gum
    *may contain this ingredient

    (Mucinex Nightshift
    Sinus Clear & Cool)

    ammonium glycyrrhizate,
    anhydrous citric acid, D&C
    yellow no. 10, edetate disodium,
    FD&C blue no. 1, flavors,
    glycerin (soy), propylene glycol,
    sodium benzoate, sorbitol,
    sucralose, water, xanthan gum

  • QUESTIONS

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PURPOSE

    Acetaminophen 650mg.......... ................Pain reliever
    Guaifenesin 400 mg.................................Expectorant
    Phenylephrine HCl 10mg. . . . . . . . . . . . . . .Nasal decongestant

    Acetaminophen 650mg..........Pain reliever/fever reducer
    Dextromethorphan HBr 20 mg..............Cough suppressant
    Phenylephrine HCl 10mg. . . . . . . . . . . . . . .. . .Nasal decongestant
    Triprolidine HCl 2.5 mg. . . . . . . . . . . . . . . . . . . . . . .Antihistamine

  • PRINCIPAL DISPLAY PANEL

    LabelLabelLabel

  • INGREDIENTS AND APPEARANCE
    MUCINEX-SINUS MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL AND MUCINEX NIGHTSHIFT SINUS CLEAR AND COOL 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-116
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-116-661 in 1 CARTON01/01/201901/29/2024
    11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 21 BOTTLE 180 mL
    Part 1 of 2
    MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN CLEAR AND COOL 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-267
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-267-66180 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 finalpart34101/01/2019
    Part 2 of 2
    MUCINEX NIGHTSHIFT   SINUS CLEAR AND COOL
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-270-66180 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 finalpart34101/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/201901/29/2024
    Labeler - RB Health (US) LLC (081049410)