SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]

SUNMARK CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [MCKESSON CORPORATION]
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NDC 49348-774-09
Set ID f94ae469-4c79-4ce9-9a3d-3bdc645be6d9
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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
    SUNMARK CHEST CONGESTION RELIEF PE  PE
    guaifenesin/phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-774
    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:49348-774-091 in 1 CARTON08/29/2019
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/05/2006
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(49348-774) , repack(49348-774)