Label: MUCINEX SINUS-MAX DAY NIGHT- acetaminophen, diphenhydramine hydrochloride, guaifenesin, phenylephrine hydrochloride kit

  • 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 October 17, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Mucinex SINUS-MAX DAYPurposes
    Acetaminophen 325 mgPain reliever
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Mucinex SINUS-MAX NIGHTPurposes
    Acetaminophen 325 mgPain reliever
    Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    Mucinex SINUS-MAX DAY

    • 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 SINUS-MAX NIGHT

    • temporarily relieves:
      • nasal congestion
      • headache
      • minor aches and pains
      • sinus congestion and pressure
      • runny nose
      • sneezing
      • cough
    • temporarily promotes nasal and/or sinus drainage
  • 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
    • 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.

    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.
    • with any other product containing diphenhydramine, even one used on the skin (NIGHT only)
    • 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
    • trouble urinating due to an enlarged prostate gland
    • glaucoma (NIGHT only)
    • a breathing problem such as emphysema or chronic bronchitis (NIGHT 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 (NIGHT only)

    When using this product

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

    • 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 older: take 2 caplets every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients (Mucinex SINUS-MAX DAY only)

    croscarmellose sodium, crospovidone, 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

  • Inactive ingredients (Mucinex SINUS-MAX NIGHT only)

    croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide

  • Questions?

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

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
    Made in England

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    MAXIMUM STRENGTH*

    NDC 63824-204-20

    Mucinex®
    SINUS-
    MAX®

    DAY

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

    Relieves Sinus Pressure,
    Headache & Congestion
    Thins & Loosens Mucus

    12
    CAPLETS

    NIGHT

    Acetaminophen – Pain Reliever
    Diphenhydramine HCl – Antihistamine/Cough Suppressant
    Phenylephrine HCl – Nasal Decongestant

    Relieves Nasal Congestion,
    Sinus Pressure & Pain
    Relieves Runny Nose,
    Sneezing & Cough

    8
    CAPLETS

    20 TOTAL
    FOR AGES 12+

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX SINUS-MAX   DAY NIGHT
    acetaminophen, diphenhydramine hydrochloride, guaifenesin, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-204
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-204-201 in 1 CARTON08/25/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 12 
    Part 22 BLISTER PACK
    Part 1 of 2
    MUCINEX SINUS-MAX   DAY
    acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (15 mpa.s at 5%) (UNII: 68401960MK)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    povidone, unspecified (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;CS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2015
    Part 2 of 2
    MUCINEX SINUS-MAX   NIGHT
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (15 mpa.s at 5%) (UNII: 68401960MK)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    aluminum oxide (UNII: LMI26O6933)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    methacrylic acid - ethyl acrylate copolymer (1:1) Type A (UNII: NX76LV5T8J)  
    mica (UNII: V8A1AW0880)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    povidone, unspecified (UNII: FZ989GH94E)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;CF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34108/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2015
    Labeler - Reckitt Benckiser LLC (094405024)