Label: PE SINUS CONGESTION- phenylephrine hcl tablet, film coated

  • NDC Code(s): 36800-704-07, 36800-704-29, 36800-704-44
  • Packager: Topco Associates, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 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?

    1-888-423-0139

  • Principal display panel

    +TopCare®
    health

    NDC 36800-704-44

    COMPARE TO SUDAFED PE®
    SINUS CONGESTION
    ACTIVE INGREDIENT*

    NON-DROWSY
    PE Sinus Congestion
    MAXIMUM STRENGTH
    PHENYLEPHRINE HCl 10 mg - NASAL DECONGESTANT

    RELIEVES:
    • Sinus Pressure
    • Sinus Congestion

    18 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

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the
    registered trademark Sudafed PE® Sinus Congestion.
    50844  ORG082045344

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007
    ©TOPCO LNKA0122
    QUESTIONS? 1-888-423-0139
    topcare@topco.com
    www.topcarebrand.com

    This TopCare® product is laboratory
    tested to guarantee its highest quality.
    Your total satisfaction is guaranteed.

    TopCare 44-453

    TopCare 44-453

  • INGREDIENTS AND APPEARANCE
    PE SINUS CONGESTION 
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-704
    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:36800-704-441 in 1 CARTON03/15/2022
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:36800-704-072 in 1 CARTON03/15/2022
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:36800-704-291 in 1 CARTON03/15/2022
    3150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/15/2022
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(36800-704) , pack(36800-704)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(36800-704)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(36800-704)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(36800-704)
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