Label: WAL-PHED- pseudoephedrine hcl tablet, film coated

  • NDC Code(s): 0363-0112-08, 0363-0112-22, 0363-0112-46
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL

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 December 17, 2022

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  • Active ingredient (in each tablet)

    Pseudoephedrine HCl 30 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 dosage.

    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 overtake 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
    children ages 6 to 11 yearstake 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
    children under 6 yearsdo not use
  • Other information

    • each tablet contains: calcium 15 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391
  • Principal Display Panel

    Walgreens

    Compare to Sudafed® Sinus
    Congestion active ingredient††

    NDC 0363-0112-22

    NON-DROWSY
    Wal-Phed® D
    NASAL DECONGESTANT

    PSEUDOEPHEDRINE HCl 30 mg / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    • Relieves sinus pressure & congestion

    48 TABLETS

    Actual Size

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

    DOES NOT CONTAIN GLUTEN

    Walgreens Pharmacist Recommended
    Walgreens Pharmacist Survey

    ††This product is not manufactured
    or distributed by Johnson &
    Johnson Corporation, owner of
    the registered trademark
    Sudafed® Sinus Congestion.

    50844    REV0619B11222

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    walgreens.com  
    ©2018 Walgreen Co.

    Walgreens 44-112

    Walgreens 44-112

  • INGREDIENTS AND APPEARANCE
    WAL-PHED 
    pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;112
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0112-464 in 1 CARTON08/25/198111/07/2024
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0112-222 in 1 CARTON08/25/198111/07/2024
    224 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0112-081 in 1 CARTON08/25/198111/07/2024
    324 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/198111/07/2024
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0363-0112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0363-0112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0363-0112)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0112)
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