Label: REFENESEN CHEST CONGESTION RELIEF- guaifenesin tablet

  • 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, 2010

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  • ACTIVE INGREDIENT

    Active ingredient - (per tablet)

    Guaifenesin  400mg  Expectoran
  • PURPOSE

    Guaifenesin ;                    Expectorant
  • INDICATIONS & USAGE

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

  • Ask a Doctor before use if you have

    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 (mucous)

    Keep out of reach of children

    In case of overdose,get medical help or contact a poison control

    cenetr immediately.

  • 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 breastfeeding, ask a health professional before use

  • DOSAGE & ADMINISTRATION

    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
  • PRINCIPAL DISPLAY PANEL

    image of carton
  • INACTIVE INGREDIENT

    collioidal silicon dioxide, magnesium stearate, microcrystalline cellulose, maltodextrin, povidone, stearic acid.

  • INGREDIENTS AND APPEARANCE
    REFENESEN CHEST CONGESTION RELIEF 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-788
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE, COLLOIDAL (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PH063
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-788-011 in 1 CARTON
    1NDC:10956-788-5050 in 1 BOTTLE, PLASTIC
    2NDC:10956-788-011 in 1 CARTON
    2NDC:10956-788-09100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/23/2003
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture
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