Label: MUCUS RELIEF CHEST CONGESTION- guaifenesin tablet, film coated

  • NDC Code(s): 11822-0532-0, 11822-0532-1, 11822-0532-3
  • Packager: Rite Aid Corporation
  • 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 November 1, 2018

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 or bothersome 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 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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  • Principal Display Panel

    RITE AID®
    PHARMACY

    mucus relief
    chest
    congestion
    guaifenesin 400 mg
    expectorant

    relieves chest congestion
    thins and loosens mucus

    ACTUAL SIZE

    IMMEDIATE RELEASE
    30 TABLETS

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

    50844      REV0812A53201

    DISTRIBUTED BY:RITE AID
    30 HUNTER LANE, CAMP HILL, PA 17011

    Rite Aid 44-532

    Rite Aid 44-532

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  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF CHEST CONGESTION 
    guaifenesin tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0532
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    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 12/22/2005 12/12/2015
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:11822-0532-0 1 in 1 CARTON 12/22/2005 07/22/2016
    2 60 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:11822-0532-1 1 in 1 CARTON 12/22/2005
    3 30 in 1 BOTTLE; Type 0: Not a Combination Product
    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 Corporation (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0532)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0532)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(11822-0532)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(11822-0532)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(11822-0532)
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