MUCUS RELIEF ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]

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MUCUS RELIEF ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [WALGREEN COMPANY]
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NDC 0363-0325-30, 0363-0325-66
Set ID 285b0e59-9a54-45a1-b2bf-454f038fff1c
Category HUMAN OTC DRUG LABEL
Packager Walgreen 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

    Compare to Maximum Strength Mucinex® active ingredient

    12 HOUR

    Mucus Relief ER

    GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg / EXPECTORANT

    MAXIMUM STRENGTH

    12 HOUR

    Relieves chest congestion

    Thins & loosens mucus

    28 EXTENDED-RELEASE TABLETS

    ACTUAL SIZE

    mucus relief ER image

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF ER 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0325
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (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:0363-0325-661 in 1 CARTON03/18/2016
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0325-301 in 1 CARTON03/18/2016
    228 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09100903/18/2016
    Labeler - Walgreen Company (008965063)
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