Label: SUPHEDRINE PE- phenylephrine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 21, 2010

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  • 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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