Label: MUCINEX- guaifenesin tablet, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 14, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release bi-layer tablet)

    Guaifenesin 600 mg

  • Purpose

    Expectorant

    12 Hour

    Unique Bi-Layer Tablet

    White Layer – Immediate Release Layer

    Blue Layer – Extended-Release Layer

  • 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 accompanied by 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 persistent headache. These could be signs of a serious illness.

    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.

    This Unit Dose package is not child resistant and is Intended for Institutional Use Only. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

    If dispensed for outpatient use, a child-resistant container should be utilized.

  • Directions

    •
    do not crush, chew, or break tablet
    •
    take with a full glass of water
    •
    this product can be administered without regard for the timing of meals
    •
    adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    •
    children under 12 years of age: do not use
  • Other information

    •
    FOR YOUR PROTECTION: Do not use if blister is torn or broken.
    •
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.

  • SPL UNCLASSIFIED SECTION

    * The name MUCINEX® and associated trademarked items are used with permission by Reckitt Benckiser

    The drug product contained in this package is from NDC # 63824-008 Reckitt Benckiser.

    Packaged and Distributed by American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

    Americanhealthpackaging.com

    An AmerisourceBergen Company

    Distributed by:

    Cardinal Health

    Dublin, OH 43017

    L5315882-10624

    L5315882-20624

    057201
    5500408/0915

  • Principal Display Panel

    MUCINEX® 600 mg

    Guaifenesin

    EXPECTORANT

    10 EXTENDED-RELEASE BI-LAYER TABLETS

    600mg bag label
  • INGREDIENTS AND APPEARANCE
    MUCINEX 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4680(NDC:68084-572)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (blue and white) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mucinex;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-4680-010 in 1 BAG01/01/2016
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128201/01/2016
    Labeler - Cardinal Health 107, LLC (118546603)
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