Label: NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet, coated 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

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  • Purpose

    Nasal decongestant

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  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
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  • 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
    • trouble urinating due to an enlarged 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.

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  • 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 
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  • 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 
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  • Inactive ingredients

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

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  • Principal display panel

    fred's®

    Maximum Strength
    Nasal Decongestant PE
    Phenylephrine HCl 10 mg | Nasal Decongestant 

    Non-Drowsy
    Sinus Pressure
    Congestion

    18 Tablets

    Compare to the active ingredient in:
    Sudafed PE® Congestion*

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

    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 McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion.
    50844    REV0313E45344

    Fred's 44-453

    Fred's 44-453

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  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT PE 
    phenylephrine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-453
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    DEXTROSE MONOHYDRATE  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C RED NO. 40  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    SILICON DIOXIDE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    TRISODIUM CITRATE DIHYDRATE  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 6mm
    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
    1 18 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/06/2004
    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)
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