Label: QUALITY CHOICE MUCUS RELIEF PE 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 April 4, 2014

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  • ACTIVE INGREDIENT

    Active ingredient - (per tablet)

    Guaifenesin   400 mg

    Phenylephrine HCl  10 mg

  • Purpose

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

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

  • 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

  • Warnings

    Do not exceed recommended dosage



  • 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.

  • 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 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.

  • PREGNANCY OR BREAST FEEDING


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

  • 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.

  • 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.

  • 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

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MUCUS RELIEF PE  PE
    guaifenesin/phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-752
    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)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code RCCGPE;C27
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-752-501 in 1 CARTON
    150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/05/2006
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(63868-752) , repack(63868-752)
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