Label: GNP MUCUS RELIEF PE- guaifenesin/phenylephrine tablet

  • NDC Code(s): 46122-700-71
  • Packager: AmerisourceBergen Drug Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • 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
    • thin bronchial secretions
  • 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

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

  • Carton Panel

    image of carton

    image description

  • INGREDIENTS AND APPEARANCE
    GNP MUCUS RELIEF  PE
    guaifenesin/phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-700
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code PH043
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-700-711 in 1 CARTON01/13/2022
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/13/2022
    Labeler - AmerisourceBergen Drug Corp (007914906)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture(46122-700)