GOOD SENSE MUCUS ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [L. PERRIGO COMPANY]

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GOOD SENSE MUCUS ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [L. PERRIGO COMPANY]
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NDC 0113-0325-66
Set ID 8dcd36a1-4d3b-4435-9b6b-a2428b5c6744
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number ANDA091009
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  • Active ingredient (in each extended-release tablet)

    Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
    •
    children under 12 years of age: do not use
  • Other information

    •
    store between 20°-25°C (68°-77°F)
    •
    do not use if printed foil under cap is broken or missing
  • Inactive ingredients

    colloidal silicon dioxide, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    12 Hour

    Maximum Strength

    Mucus - ER

    Guaifenesin Extended-Release Tablets, 1200 mg

    Expectorant

    Relieves Chest Congestion

    Thins and Loosens Mucus

    Compare to active ingredient of Maximum Strength Mucinex®

    100% SATISFACTION GUARANTEED

    14 Extended-Release Tablets

    325-c2-mucus er.jpg
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE MUCUS ER 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorBLUE (Light Blue) Scoreno score
    ShapeOVAL (Biconvex) Size22mm
    FlavorImprint Code Watson;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0325-661 in 1 CARTON09/19/2017
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09100909/19/2017
    Labeler - L. Perrigo Company (006013346)
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