QUALITY CHOICE MUCUS RELIEF (GUAIFENESIN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]

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QUALITY CHOICE MUCUS RELIEF (GUAIFENESIN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-998-50
Set ID 41f88b43-3e0a-4650-b167-a72afe6177e8
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Active ingredient (per tablet)

    Guaifenesin  400mg

  • Purpose

    Expectorant

  • Uses

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

    Ask doctor before use if you have

    • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
    • cough is accompanied by excessive phlegm (mucus)
  • STOP USE

    Stop use and ask doctor if

    • Symptoms are accompanied by fever, rash or persistent headache
    • cough persists for more than 1 week or tends to recur
    A persistent cough may be a sign of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control

    Center immediately.

  • Directions

    • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
    • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
    • Children under 6 years of age: consult a doctor    
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor
  • Other Information

    store at 15°-30°C (59°-86°F)

  • Inactive ingredients

    magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MUCUS RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-998
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE (UNII: D9C330MD8B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PH063
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-998-501 in 1 CARTON08/01/2012
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2012
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(63868-998) , repack(63868-998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture(63868-998)
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