Label: MUCUS RELIEF CHEST- guaifenesin tablet, coated

  • 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 09/11

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

  • Active ingredient(s)

     Guaifenesin 400 mg

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  • Purpose

     Expectorant

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  • Use(s)

     helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways or bothersome mucus and make coughs more productive

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  • Warnings

    Ask a doctor before use if you have

    • cough tha 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 ebd 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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  • Principal Display Panel

    Product Packaging

    RITE

    AID®

    PHARMACY

    Guaifenesin 400 mg

    Mucus Relief

    Chest

    Exopectorant

    Immediate-release

    Relieves Chest Congestion

    Thins And Loosens Mucus

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    50844      ORG051043203

    DISTRIBUTED BY:

    Rite Aid

    30 Hunter Lane, Camp Hill, PA 17011

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF CHEST 
    guaifenesin tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0532
    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  
    POLYETHYLENE GLYCOL  
    POVIDONE  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    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:11822-0532-3 1 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/22/2005
    Labeler - Rite Aid (014578892)
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