Label: WAL PHED- pseudoephedrine hydrochloride tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

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 08/09

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

  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 120 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged 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 a 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 right away. (1-800-222-1222)

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  • Directions

    adults and children 12 years and over
    • take 1 tablet every 12 hours
    • do not take more than 2 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

    • each tablet contains: calcium 45 mg
    • store at 20° - 25°C (68° - 77°F) in a dry place
    • protect from light
    • do not use if blister unit is broken or torn
    • see carton end panel for lot number and expiration date
    • this product meets the requirements of USP Drug Release Test 3
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Sudafed® 12 Hour active ingredient

    Non-Drowsy

    Sinus

    Wal-Phed®

    Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

    Long-Acting Nasal Decongestant

    12 Hour

    Sinus Pressure - Congestion

    Maximum Strength

    Pseudoephedrine HCl

    120 mg Each

    *Capsule-Shaped Tablets

    Caplets

    Wal-Phed(R) Carton Image 1

    Wal-Phed(R) Carton Image 1

    Wal-Phed(R) Carton Image 2

    Wal-Phed(R) Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    WAL PHED 
    pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0054
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    COLLOIDAL SILICON DIOXIDE  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL  
    POLYSORBATE 80  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code L054
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0054-60 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075153 09/24/1999
    Labeler - Walgreen Company (008965063)
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