Label: MUCUS RELIEF CHEST- guaifenesin tablet 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • Active ingredient (in each immediate-release 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 bothersom 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 that occurs with 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.

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  • Directions

    • take with a full glass of water
    • adults and children 12 years of age and over: 1 tablet, every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: do not use 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    NDC 49035-555-11

    Immediate-Release

    Mucus
    Relief
    Chest
    Guaifenesin 400 mg • Expectorant

    Relieves Chest Congestion
    Thins and Loosens Mucus

    QUALITY GUARANTEED

    60
    Tablets

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

    50844    REV0812D53211

    Wal-Mart 44-532

    Wal-Mart 44-532

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF CHEST 
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-555
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape ROUND Size 13mm
    Flavor Imprint Code 44;532
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-555-11 1 in 1 CARTON
    1 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/22/2005
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-555, 49035-555, 49035-555)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-555, 49035-555, 49035-555)
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