Label: MUCINEX FAST-MAX CHEST CONGESTION HONEY AND BERRY FLAVOR- guaifenesin solution

  • 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 January 19, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 20 mL)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Do not use

    • for children under 12 years of age

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if

    • cough lasts more than 7 days, 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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 at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, 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 - 180 mL Bottle Label

    MAXIMUM STRENGTH
    NDC 63824-537-66

    Mucinex®
    FAST-MAX®

    CHEST CONGESTION

    Honey
    & Berry Flavor

    Guaifenesin – Expectorant

    ✓
    Relieves Chest Congestion
    ✓
    Thins & Loosens Mucus
    ✓
    4 Hour Dosing

    6 FL OZ (180 mL)
    FOR AGES 12+

    010720
    3132639

    Principal Display Panel - 180 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX CHEST CONGESTION HONEY AND BERRY FLAVOR 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-537
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ammonium glycyrrhizate (UNII: 3VRD35U26C)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    edetate disodium (UNII: 7FLD91C86K)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-537-66180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/01/2020
    Labeler - RB Health (US) LLC (081049410)
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