WAL-PHED PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WALGREEN COMPANY]

WAL-PHED PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET [WALGREEN COMPANY]
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NDC 0363-0462-07, 0363-0462-08
Set ID 5bd2ef2c-7eb7-4d57-8c85-691a243f18d8
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each tablet)

    Chlorpheniramine maleate 4 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itching of the nose or throat
      • itchy, watery eyes
      • sinus congestion and pressure
      • nasal congestion
  • 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

    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery

    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 (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
  • Other information

    • 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, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Walgreens

    Compare to Sudafed PE®
    Sinus + Allergy active ingredients††

    NDC 0363-0462-08

    Wal-Phed® PE
    SINUS & ALLERGY

    CHLORPHENIRAMINE MALEATE 4 mg / ANTIHISTAMINE
    PHENYLEPHRINE HCl 10 mg / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    • Relieves sneezing, itchy eyes, runny nose,
      sinus pressure & congestion
    • Pseudoephedrine free

    24 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 McNeil Consumer
    Healthcare, owner of the registered
    trademark Sudafed PE® Sinus + Allergy.

    50844    REV0319D46208

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens
    100% SATISFACTION
    GUARANTEED

    walgreens.com      ©2018 Walgreen Co.

    Walgreens 44-462

    Walgreens 44-462

  • INGREDIENTS AND APPEARANCE
    WAL-PHED PE  MAXIMUM STRENGTH
    chlorpheniramine maleate and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0462
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 44;462
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0462-081 in 1 CARTON06/09/2005
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0462-073 in 1 CARTON06/09/2005
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/09/2005
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0363-0462)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0462)