Label: NASAL DECONGESTANT PE MAXIMUM STRENGTH NON-DROWSY- phenylephrine 10 mg tablet

  • NDC Code(s): 69168-272-17, 69168-272-82, 69168-272-93
  • Packager: Allegiant Health
  • 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 November 7, 2018

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  • Active ingredient

    Phenylephrine HCl 10 mg

  • Purpose

    Nasal Decongestant

  • Uses

    temporarily relieves:

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

    Do not use

    Do not use if you are now taking a prescription mono-amine 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 you have

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

    When using this product

    do not use more than directed

    Stop use and ask a doctor if
    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by fever
  • Keep Out of Reach of Children

    In case of accidentaloverdose, contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years of age and older: 
    • 1 tablet every 4 to 6 hours. 
    • Do not take more than 6 tablets in 24 hours
    • Children under 12 years of age: ask a doctor
  • Inactive Ingredients

    croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • If pregnant or breast-feeding,

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

  • Principal Display Panel

    Decongestant

    Decongestant


  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE  MAXIMUM STRENGTH NON-DROWSY
    phenylephrine 10 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-272
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-272-931 in 1 CARTON12/23/2014
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69168-272-17300 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021
    3NDC:69168-272-8290 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
    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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