Label: NASAL DECONGESTANT PE- phenylephrine hcl tablet, film coated

  • NDC Code(s): 0363-4531-02, 0363-4531-07, 0363-4531-23, 0363-4531-44
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 21, 2024

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  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

  • Purpose

    Nasal decongestant

  • Uses

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

    Do not use

    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 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
    • diabetes
    • thyroid disease
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    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 right away.

  • Directions

    • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

    Compare to the active ingredient in 
    Sudafed PE® Sinus Congestion ††

    NDC 0363-4531-07

    NON-DROWSY 

    Nasal Decongestant PE

    PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT

    Maximum Strength

    • Relieves sinus pressure & congestion      • Pseudoephedrine free

    36
    TABLETS

    ACTUAL SIZE

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    †Our pharmacists recommend the
    Walgreens brand. We invite you to
    compare to national brands.
    ††This product is not manufactured
    or distributed by Johnson &
    Johnson Corporation, owner of
    the registered trademark Sudafed
    PE® Sinus Congestion.

    50844     ORG082045307

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com
    ©2021 Walgreen Co.

    Walgreens 44-453

    Walgreens 44-453

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT  PE
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4531
    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)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4531-441 in 1 CARTON01/21/2022
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-4531-234 in 1 CARTON01/21/2022
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-4531-072 in 1 CARTON01/21/2022
    318 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0363-4531-021 in 1 CARTON01/21/202208/09/2025
    412 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/21/2022
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0363-4531) , pack(0363-4531)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0363-4531)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(0363-4531)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(0363-4531)
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