SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION]

SUPHEDRINE PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION]
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NDC 63981-453-69
Set ID e6731360-a309-1652-6c43-5235076c18a4
Category HUMAN OTC DRUG LABEL
Packager COSTCO WHOLESALE CORPORATION
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

  • 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 relives 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
    • high blood pressure
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
  • When using this product

    do not exceed the recommended dosage

  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of the 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: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. 
    • children under 12 years: do not use this product in children under 12 years of age
  • Other information

    • store at controlled room temperature 15°-30°C (59° to 86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium cardoxymethylcellulose, sodium citrate dihydrate, titanium dioxide

  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may aslo be available.

    KIRKLAND

    Signature™

    COMPARE TO

    SUDAFED PE™

    active ingredient*

    NDC 63981-453-69

    ITEM # 111266

    NON-DROWSY

    SUPHEDRINE PE

    Phenylephrine Hydrochloride 10 mg

    Nasal & Sinus Decongestant Formula

    Temporary Relief of:

    Nasal Congestion

    Sinus Pressure & Congestion

    Hay Fever Symptoms

    Actual Size

    1 Pill Per Dose

    144

    TABLETS

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

    50844       REV0810F45369

    Manufactured by:

    LNK INTERNATIONAL, INC.

    60 Arkay Drive, Hauppauge, NY 11788 USA

    For Costco Wholesale Corporation

    P.O. Box 34535

    Seattle, WA 98124-1535 USA

    1-800-774-2678

    www.cvs.com

    Product Label
  • INGREDIENTS AND APPEARANCE
    SUPHEDRINE PE  
    phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-453
    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)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Trisodium Citrate Dihydrate (UNII: B22547B95K)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 44;453
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-453-691 in 1 CARTON
    1144 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/06/2004
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Registrant - L.N.K. International, Inc. (832867837)
    Establishment
    NameAddressID/FEIBusiness Operations
    L.N.K. International, Inc832867894MANUFACTURE

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