Label: MUCUS- guaifenesin tablet, extended release

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

Drug Label Information

Updated December 14, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release tablet)

    Guaifenesin 600 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 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 (1-800-222-1222).

  • 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

    •
    Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
    •
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    (1-800-406-7984)

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by C.D.M.A., Inc.©
    43157 W. Nine Mile
    Novi, MI 48375

  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

    QUALITY
    CHOICE

    NDC 63868-389-20

    †Compare to
    Active Ingredient in
    Mucinex®

    Mucus Relief
    Guaifenesin
    Extended-Release
    Tablets 600 mg

    Expectorant

    12 Hour

    •
    Relieves Chest Congestion
    •
    Thins and Loosens Mucus
    •
    Immediate and Extended Release

    20 Extended-Release Tablets

    PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    MUCUS 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-389
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mxeunic;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-389-201 in 1 CARTON02/08/2018
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128202/08/2018
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(63868-389)
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