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 February 13, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:  Each immediate-release tablet contains – Guaifenesin 400 mg

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  • PURPOSE

    PURPOSE:  Expectorant

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN:  In case of overdose, get medical help or contact a Poison Control Center right away

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  • INDICATIONS & USAGE

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

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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 excessive phlegm (mucus)

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  • DOSAGE & ADMINISTRATION

    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 doses in 24 hours.

    Children under 12 years of age do not use.

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  • INACTIVE INGREDIENT

    Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

    Generic Section

    Distributed By:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152

    Refer to package label for Distributor's NDC Number

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  • Principal Display Panel

    Mucus Relief

    Guaifenesin 400 mg

    30 Tablets

    label
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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6232(NDC:49483-272)
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 12mm
    Flavor Imprint Code TCL272
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6232-46 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/23/2012
    2 NDC:0904-6232-52 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/23/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/23/2012
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
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