Label: UP AND UP MUCUS RELIEF- guaifenesin tablet, extended release

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

Drug Label Information

Updated November 7, 2019

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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?

    1-888-547-7400

  • Package/Label Principal Display Panel

    Compare to active ingredient in Maximum Strength Mucinex®

    maximum strength

    mucus relief

    guaifenesin extended-release tablets, 1200 mg

    expectorant

    relieves chest congestion

    thins land loosens mucus

    12 HOUR

    ACTUAL SIZE

    28 TABLETS

    28 EXTENDED-RELEASE TABLETS

    Up & Up Mucus Relief image
  • INGREDIENTS AND APPEARANCE
    UP AND UP MUCUS RELIEF 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-325
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    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:11673-325-661 in 1 CARTON07/11/201611/30/2019
    114 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11673-325-301 in 1 CARTON07/11/201607/02/2018
    228 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09100907/11/2016
    Labeler - Target Corporation (006961700)
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