Label: LEADER CHEST CONGESTION RELIEF PE- guaifenesin/phenylephrine 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 January 26, 2011

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  • ACTIVE INGREDIENT

    Guaifenesin                             400 mg

    Phenylephrine HCl                   10 mg

  • PURPOSE

    Guaifenesin                               Expectorant

    Phenylephrine HCl                   Nasal decongestant

  • INDICATIONS & USAGE

    temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

    helps loosen phlegm;mucus

    clear nasal passageways

    loosens nasal congestion

    drain bronchial tubes

    shrinks swollen membranes

    clears stuffy nose

    makes coughs more productive

  • WARNINGS

    do not exceed recommended dosage

  • DO NOT USE

    Do not use this product if you are now taking a prescription Monoamine Oxidase inhibitor ; MAIO,

    certain drugs for depression,psychiatric or emotional conditions, or Parkinsons Disease or for 2 weeks

    after stopping the MAIO drug,if you are uncertain whether your prescription contains an MAIO ,

    ask a health professional.

  • ASK DOCTOR

    ask a doctor before use if you have

    heart disease

    high blood pressure

    thyroid disease

    diabetes

    excessive phlegm;mucus

    difficulty in urination due to an enlarged prostate gland

    persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

  • STOP USE

    stop use and ask a doctor if

    nervousness,dizziness or sleeplessness occurs

    symptoms are accompanied by fever,rash,persistent headache or excessive phlegm;mucus.

    cough and congestion do not approve within 7 days or tend to recur

    these could be signs of a serious condition

  • PREGNANCY 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 immediately.

  • DOSAGE & ADMINISTRATION

    directions

    Adults and Children 12 years of age and over take 1 caplet every 4 hours as needed

    children 6 to under 12 years of age consult a doctor

    do not exceed 6 doses in a 24 hour period or as directed by a doctor.

  • INACTIVE INGREDIENT

    croscarmellose sodium,hypromellose,lactose,magnesium silicate,

    magnesium stearate,maltodextrin,mycocrystalline cellulose,mineral oil,povidone,

    silica,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin.

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    LEADER CHEST CONGESTION RELIEF  PE
    guaifenesin/phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-874
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code RCCGPE;C27
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-874-011 in 1 CARTON
    1NDC:37205-874-7150 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/05/2006
    Labeler - Cardinal Health (097537435)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel, repack
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