Label: MUCUS RELIEF- guaifenesin tablet, film coated

  • NDC Code(s): 63981-532-03, 63981-532-06, 63981-532-36
  • Packager: COSTCO WHOLESALE CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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

  • Active ingredient (in each immediate-release tablet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

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

  • Warnings

    Ask a doctor before use if you have

    • cough accompanied by 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 persists more than 7 days, tends to recur, or is accompanied by a 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.

  • Directions

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

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

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

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    KIRKLAND
    Signature

    IMMEDIATE-RELEASE
    EXPECTORANT
    TABLETS

    NDC 63981-532-06
    ITM. / ART. 363881 

    MUCUS RELIEF
    CHEST
    Guaifenesin, 400 mg
    Expectorant

    Actual Size

    Relieves Chest Congestion
     
    Thins and Loosens Mucus
    Makes Coughs More Productive

    2 x 200
    Immediate-Release
    Tablets

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

    50844      REV0118H53206
    Manufactured by: LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788 USA

    For: Costco Wholesale Corporation
    P.O. Box 34535, Seattle, WA 98124-1535 USA
    1-800-774-2678
    www.costco.com

    Kirkland 44-532

    Kirkland 44-532


  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF 
    guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-532
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code 44;532
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-532-062 in 1 CARTON12/22/2005
    1200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:63981-532-031 in 1 CARTON12/22/200511/19/2022
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63981-532-361 in 1 CARTON12/22/200511/23/2021
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/22/2005
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(63981-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(63981-532) , pack(63981-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(63981-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(63981-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(63981-532)