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Nasal Decongestant PE (FRED'S, INC.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BLISTER PACK in 1 CARTON (55315-453-44) > 18 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Nasal Decongestant PE Information

  • 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 dose.

    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: do not use this product in children under 12 years of age 

  • 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, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide


  • Principal display panel

    fred's®

    Maximum Strength
    Nasal Decongestant PE

    Phenylephrine HCl 10 mg | Nasal Decongestant 

    Non-Drowsy
    Sinus Pressure
    Congestion

    18 Tablets

    fred's
    LAB TESTED®
    Lab Tested for Quality,
    Fred Tested for Satisfaction

    Compare to the
    active ingredient in:

    Sudafed PE®
    Congestion*

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

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com

    fred's Promise
    Not Happy With This Product?
    Just Bring it Back for a Refund!

    *This product is not manufactured or distributed by
    McNeil Consumer Healthcare, owner of the registered
    trademark Sudafed PE® Congestion.
    50844    REV0715F45344Freds 44-453

    Freds 44-453


  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE 
    phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-453
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    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, UNSPECIFIED FORM (UNII: K679OBS311)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code 44;453
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-453-44 1 in 1 CARTON 01/14/2005
    1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 01/14/2005
    Labeler - FRED'S, INC. (005866116)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55315-453)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55315-453)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(55315-453)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(55315-453)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(55315-453)