Label: LEADER CHEST CONGESTION RELIEF PE- guaifenesin and phenylephrine hydrochloride tablet

  • NDC Code(s): 37205-874-01, 37205-874-71
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/11

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

  • ACTIVE INGREDIENT

    Guaifenesin                             400 mg

    Phenylephrine HCl                   10 mg

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  • PURPOSE

    Guaifenesin                               Expectorant

    Phenylephrine HCl                   Nasal decongestant

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  • 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

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  • WARNINGS

    do not exceed recommended dosage

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  • 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.

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  • 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

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  • 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

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  • PREGNANCY OR BREAST FEEDING

    ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    in case of overdose,get medical help or contact a Poison Control Center immediately.

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  • 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.

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    LEADER CHEST CONGESTION RELIEF  PE
    guaifenesin/phenylephrine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-874
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 400 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    LACTOSE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POVIDONE  
    MAGNESIUM SILICATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL Size 17mm
    Flavor Imprint Code RCCGPE;C27
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-874-01 1 in 1 CARTON
    1 NDC:37205-874-71 50 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/05/2006
    Labeler - Cardinal Health (097537435)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    Name Address ID/FEI Business Operations
    Reese Pharmaceutical Co 004172052 relabel, repack
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