Label: MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF- acetaminophen, guaifenesin and phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 63824-201-20, 63824-201-30
  • Packager: Reckitt Benckiser LLC
  • 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 08/12

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) Purpose
    Acetaminophen 325 mg Pain reliever
    Guaifenesin 200 mg Expectorant
    Phenylephrine HCl 5 mg Nasal decongestant
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  • Uses

    • 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
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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 containing 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.
    • 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
    • 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

    • 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 rash or persistent headache. 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 (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

    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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  • 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

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  • PRINCIPAL DISPLAY PANEL - 20 Caplet Carton

    MAXIMUM STRENGTH*

    NDC 63824-201-20

    NEW

    Mucinex®
    SINUS-MAX™

    Severe Congestion Relief
    Acetaminophen
    - Pain Reliever • Guaifenesin - Expectorant
    Phenylephrine HCl - Nasal Decongestant

    Clears Sinus Congestion
    Relieves Headache
    Thins & Loosens Mucus

    For Ages 12+

    20
    CAPLETS

    PRINCIPAL DISPLAY PANEL - 20 Caplet Carton
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  • INGREDIENTS AND APPEARANCE
    MUCINEX SINUS-MAX   SEVERE CONGESTION RELIEF
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-201
    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  
    povidone  
    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 NDC:63824-201-20 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:63824-201-30 3 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/23/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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