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

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 DrugM01212/23/2014
    Labeler - Allegiant Health (079501930)
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