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

  • NDC Code(s): 63824-115-66, 63824-266-66, 63824-269-66
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL

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 June 8, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)
    Mucinex Sinus-Max Severe Congestion & Pain
    Purposes
    Acetaminophen 650mgPain reliever
    Guaifenesin 400 mgExpectorant
    Phenylephrine HCl 10 mgNasal decongestant
  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)
    Mucinex Nightshift Sinus
    Purposes
    Acetaminophen 650mgPain reliever/fever reducer
    Dextromethorphan HBr 20 mgCough suppressant
    Phenylephrine HCl 10 mgNasal decongestant
    Triprolidine HCl 2.5 mgAntihistamine
  • Uses

    Mucinex Sinus-Max Severe Congestion & Pain

    • 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

    • 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

    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 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

    • 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
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma (Nightshift Sinus only)
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis (Nightshift Sinus 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 only)

    When using this product

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

    • 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

    • 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 information

    • each 20 mL contains: sodium 12 mg (Sinus-Max Severe Congestion & Pain only) and sodium 16 mg (Nightshift Sinus only)
    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients (Mucinex Sinus-Max Severe Congestion & Pain)

    anhydrous citric acid, edetate disodium, FD&C blue no.1, FD&C red no. 40, flavors, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum


    1
    may contain this ingredient
  • Inactive ingredients (Mucinex Nightshift Sinus)

    ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

  • Questions?

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

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US), Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    DAY & NIGHT
    SINUS CONGESTION & PAIN RELIEF

    MAXIMUM STRENGTH*

    NDC 63824-115-66

    Mucinex®
    SINUS-MAX®

    SEVERE CONGESTION
    & PAIN

    Acetaminophen – Pain Reliever
    Guaifenesin – Expectorant
    Phenylephrine HCl – Nasal Decongestant

    • Clears Sinus Congestion
    • Relieves Headache
    • Thins & Loosens Mucus

    FOR
    AGES 12+

    Mucinex®
    NIGHTSHIFT

    SINUS

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Phenylephrine HCl – Nasal Decongestant
    Triprolidine HCl – Antihistamine

    NIGHTTIME
    RELIEF FOR A BETTER
    MORNING

    ✓COUGH ✓FEVER ✓SORE THROAT
    ✓RUNNY NOSE ✓SNEEZING ✓NASAL CONGESTION

    FOR
    AGES 12+

    TWO – 6 FL OZ (180 mL) bottles
    TOTAL – 12 FL OZ (360 mL)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN AND MUCINEX NIGHTSHIFT SINUS 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-115
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-115-661 in 1 CARTON05/30/2022
    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 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-266
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-266-66180 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 finalpart34105/30/2022
    Part 2 of 2
    MUCINEX NIGHTSHIFT   SINUS
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC:63824-269
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-269-66180 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 finalpart34105/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/30/2022
    Labeler - RB Health (US) LLC (081049410)