MUCUS RELIEF MAXIMUM STRENGTH (GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]

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MUCUS RELIEF MAXIMUM STRENGTH (GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]
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NDC 55301-532-11
Set ID 4263de9d-f472-48bc-8b1e-2db4df299556
Category HUMAN OTC DRUG LABEL
Packager ARMY AND AIR FORCE EXCHANGE SERVICE
Generic Name
Product Class
Product Number
Application Number PART341
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  • 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 (1-800-222-1222) 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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

    exchange✓select™

    MAXIMUM STRENGTH
    Mucus Relief
    Guaifenesin 400 mg
    Expectorant

    Immediate Release

    4 Hours of Relief

    Relieves Chest Congestion
    Thins & Loosens Mucus

    Film Coated
    60 Tablets

    Actual Size

    ✓quality value

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

    "SATISFACTION GUARANTEED OR YOUR MONEY BACK"
    Manufactured For Your Military Exchanges
    Distributed by: LNK International, Inc.
    Hauppauge, NY 11788
    1-800-426-9391

    50844 REV0118E53211

    Exchange Select 44-532

    Exchange Select 44-532

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF  MAXIMUM STRENGTH
    guaifenesin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-532
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeROUNDSize13mm
    FlavorImprint Code 44;532
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-532-116 in 1 CARTON12/22/2005
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/22/2005
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(55301-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(55301-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(55301-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(55301-532)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(55301-532)
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