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

  • 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 01/13

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

  • ACTIVE INGREDIENT

    Active ingredient - (per tablet)

    Guaifenesin   400 mg

    Phenylephrine HCl  10 mg

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  • Purpose

    Guaifenesin.......................Expectorant

    Phenylephrine HCl..............Nasal decongestant

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  • Uses

    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

    ■ this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
    psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the
    MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health
    professional.

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  • 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 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 improve within 7 days
    or tend to recur.
    These could be signs of a serious condition.

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  • PREGNANCY OR BREAST FEEDING


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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison
    Control Center immediately.

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  • Directions


    ■ adults and children 12 years and over:
    take 1 caplet every 4 hours as needed
    ■ children 6 to under 12 years:
    take 1/2 caplet every 4 hours as needed
    ■ children under 6 years: consult a doctor
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

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  • Inactive ingredients

    lactose, magnesium silicate,
    croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin,
    microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid,
    titanium dioxide and triacetin

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  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS CHEST CONGESTION RELIEF  PE
    guaifenesin/phenylephrine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-014
    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:61715-014-01 1 in 1 CARTON
    1 NDC:61715-014-50 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 - Kinray (012574513)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    Name Address ID/FEI Business Operations
    Reese Pharmaceutical Co 004172052 relabel(61715-014), repack(61715-014)
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