Label: DECONGESTANT PE NON DROWSY- phenylephrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 16, 2021

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  • Active ingredient(s)

    Phenylephrine HCl 5mg

  • Purpose

    Nasal decongestant

  • Use(s)

    • temporarily relieves sinus congestion and
      pressure
    • temporarily relieves nasal congestion due to the
      common cold, hay fever or other upper respiratory
      allergies
  • Warnings

    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 do not know if your prescription drug
    contains an MAOI, ask a doctor or pharmacist before
    taking this product.

    Ask a doctor before use if

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product

    do not exceed recommended dose

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    Pregnancy/Breastfeeding

    ask a health professional before use

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years and over: 1 tablet every 4 hours

    • do not take more than 6 tablets in 24 hours

    Children under 12 years ask a doctor

  • Other information

    • do not use if imprinted safety seal under cap is broken or missing
  • Storage

    • store at room temperature 20°– 25°C (68°– 77°F)
  • Inactive ingredients

    croscarmellose sodium, lactose, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,

    hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide.

    May contain propylene glycol

  • Questions

    Call 1-888-952-0050 Monday through Friday

  • Principal Display Panel

    Decongestant PE 5mg

    Decongestant PE 5mg


  • INGREDIENTS AND APPEARANCE
    DECONGESTANT PE  NON DROWSY
    phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-271
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-271-17300 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/23/2014
    Labeler - Allegiant Health (079501930)
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