Label: MUCUS RELIEF- guaifenesin tablet 

  • 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 10/12

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

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 

    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 controlled room temperature 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

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

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  • Questions?

     To Report Adverse Drug Event Call: (800) 616-2471

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  • Principal Display Panel

    NDC 68196-532-06      chest congestion

    SIMPLY RIGHT
    Health Care

    mucus relief
    guaifenesin | expectorant

    releives chest congestion, thins and loosens mucus

    1 tablet dose
    immediate release

    200 tablets

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

    50844     ORG051053206

    Distributed by:
    SAM"S West, Inc.
    Bentonville, AR 72716

    Simply Right 44-532

    Simply Right 44-532

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68196-532
    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:68196-532-06 1 in 1 CARTON
    1 200 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 - Sam's West Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(68196-532)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(68196-532)
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