Label: MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Mucinex SINUS-MAX Day
    Purpose
    Acetaminophen 325 mg Pain reliever
    Guaifenesin 200 mg Expectorant
    Phenylephrine HCl 5 mg Nasal decongestant
    Active ingredients (in each caplet)
    Mucinex SINUS-MAX Night
    Purpose
    Acetaminophen 325 mg Pain reliever
    Diphenhydramine HCl 25 mg Antihistamine
    Phenylephrine HCl 5 mg Nasal decongestant
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  • Uses

    • temporarily relieves:
      • nasal congestion
      • headache
      • minor aches and pains
      • sinus congestion and pressure
      • runny nose and sneezing (Mucinex SINUS-MAX Night only)
    • 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 Day only)
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  • 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 that contain acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    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 drug containing diphenhydramine, even one used on the skin (Mucinex SINUS-MAX 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 (Mucinex SINUS-MAX Night only)
    • a breathing problem such as emphysema or chronic bronchitis (Mucinex SINUS-MAX Night only)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema (Mucinex SINUS-MAX Day only)
    • cough that occurs with too much phlegm (mucus) (Mucinex SINUS-MAX Day only)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Mucinex SINUS-MAX Night only)

    When using this product

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

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • pain or nasal congestion 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 persistent headache. These could be signs of a serious condition. (Mucinex SINUS-MAX Day only)

    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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

    • store at 20-25°C (68-77°F)
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  • Inactive ingredients (Mucinex SINUS-MAX Day)

    croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

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  • Inactive ingredients (Mucinex SINUS-MAX Night)

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

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  • Questions?

    1-866-MUCINEX (1-866-682-4639)
    You may also report side effects to this phone number.

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  • SPL UNCLASSIFIED SECTION

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

    Made in England (Mucinex SINUS-MAX Day)

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  • PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

    MAXIMUM STRENGTH*

    NDC 63824-202-20

    NEW

    Mucinex®
    SINUS-MAX

    Day

    Acetaminophen - Pain Reliever • Guaifenesin - Expectorant
    Phenylephrine HCl - Nasal Decongestant

    10
    CAPLETS

    Relieves Sinus Pressure,
    Headache & Congestion
    Thins & Loosens Mucus

    For Ages 12+

    Night

    Acetaminophen - Pain Reliever • Diphenhydramine HCl - Antihistamine
    Phenylephrine HCl - Nasal Decongestant

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

    10
    CAPLETS

    PRINCIPAL DISPLAY PANEL - 20 Caplet Carton
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  • INGREDIENTS AND APPEARANCE
    MUCINEX SINUS-MAX DAY NIGHT  MAXIMUM STRENGTH
    acetaminophen, guaifenesin, phenylephrine hydrochloride, and diphenhydramine hydrochloride kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-202
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-202-20 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 BLISTER PACK 10 
    Part 2 2 BLISTER PACK 10 
    Part 1 of 2
    MUCINEX SINUS-MAX DAY  MAXIMUM STRENGTH
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Guaifenesin (Guaifenesin) Guaifenesin 200 mg
    Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    croscarmellose sodium  
    crospovidone  
    FD&C red no. 40  
    FD&C yellow no. 6  
    aluminum oxide  
    magnesium stearate  
    cellulose, microcrystalline  
    polyethylene glycols  
    polyvinyl alcohol  
    povidones  
    talc  
    titanium dioxide  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code VVV;CS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/10/2012
    Part 2 of 2
    MUCINEX SINUS-MAX NIGHT  MAXIMUM STRENGTH
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 25 mg
    Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    starch, corn  
    croscarmellose sodium  
    crospovidone  
    FD&C blue no. 1  
    aluminum oxide  
    hypromelloses  
    magnesium stearate  
    cellulose, microcrystalline  
    polydextrose  
    polyethylene glycols  
    povidones  
    silicon dioxide  
    stearic acid  
    titanium dioxide  
    triacetin  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code 44;544
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/10/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/10/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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