Label: MUCUS RELIEF- guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 26, 2014

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  • Active ingredient (in each tablet)

    Guaifenesin 400 mg

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  • Purpose

    Expectorant

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  • Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

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  • Warnings

    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 condition.

    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)

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  • Directions

    • adults and children 12 years of age and older:
      • take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours.
    • children under 12 years of age: do not use 
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  • Other information

    • each tablet contains: sodium 5 mg
    • store at 20-25ºC (68-77ºF)
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  • Inactive ingredients

    colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

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  • Principal Display Panel

    Mucus Relief

    Guaifenesin 400 mg

    Expectorant

    • Relieves chest congestion
    • Thins and loosens mucus

    TABLETS

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

    Comments or Questions? 1-800-632-6900

    www.kroger.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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  • Product Label

    Guaifenesin 400 mg

    Kroger Mucus Relief Tablet

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-107
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 13mm
    Flavor Imprint Code TCL272;G1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-107-30 1 in 1 BOX
    1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/06/2010
    Labeler - The Kroger Co. (006999528)
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