Label: DECONGESTANT PE NON DROWSY- phenylephrine hcl 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 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

    Decongestant


  • 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 finalpart34112/23/2014
    Labeler - Allegiant Health (079501930)
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