SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.]

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  • SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.]

SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.]
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NDC 64092-802-18
Set ID 0b93ed6b-8a45-4f7e-b092-4465f99a2df5
Category HUMAN OTC DRUG LABEL
Packager GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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

    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease
    • 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 (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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?

    Call 1-800-426-9391

  • Principal Display Panel

    HEALTHCARE™

    NDC 64092-802-18

    *Compare to the active ingredient in Sudafed PE®  Congestion

    Maximum Strength

    Suphedrine PE
    Phenylephrine HCl 10 mg
    Nasal Decongestant

    Relieves:
    • Nasal & Sinus Congestion due to Colds & Allergies

    Pseudoephedrine FREE

    Non-Drowsy

    18 TABLETS

    *This product is not manufactured or distributed by Johnson &
    Johnson Corporation, owner of the registered trademark
    Sudafed PE® Congestion.   50844      REV0118G45344

    Distributed by:
    Great Lakes Wholesale
    & Marketing L.L.C.
    3729 Patterson Ave., S.E.
    Grand Rapids, MI 49512
    www.glwholesale.com

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this
    product, regardless of reason, return your unused
    portion to Great Lakes Wholesale for a full refund

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

    Healthcare 44-453

    Healthcare 44-453

  • INGREDIENTS AND APPEARANCE
    SUPHEDRINE PE 
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-802
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-802-181 in 1 CARTON01/14/2005
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/14/2005
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(64092-802)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(64092-802)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(64092-802)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(64092-802)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(64092-802)
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