Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain

Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain

Drug Labeling and Warnings

Drug Details

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MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN- acetaminophen, guaifenesin, and phenylephrine hydrochloride solution 
RB Health (US) LLC

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.

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Maximum Strength Mucinex® Sinus-Max® Severe Congestion and Pain

Drug Facts

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650 mgPain reliever
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

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

Warnings

Liver warning

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

  • more than 6 doses 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.
  • 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 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
  • 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 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 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

Other information

  • each 20 mL contains: sodium 12 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum


  • 1 may contain this ingredient
  • Questions?

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

    You may also report side effects to this phone number.

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

    PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

    MAXIMUM STRENGTH*
    NDC: 63824-266-66

    Mucinex®
    SINUS-
    MAX®

    SEVERE CONGESTION
    & PAIN

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

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

    6 FL OZ (180 mL)
    FOR AGES 12+

    030817
    3045443

    Principal Display Panel - 180 mL Bottle Label
    MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem 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)  
    glycerin (UNII: PDC6A3C0OX)  
    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)03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2018
    Labeler - RB Health (US) LLC (081049410)

    Revised: 2/2020
     
    RB Health (US) LLC


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