WAL-PHED PE MAXIMUM STRENGTH, NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WALGREEN COMPANY]

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  • WAL-PHED PE MAXIMUM STRENGTH, NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WALGREEN COMPANY]

WAL-PHED PE MAXIMUM STRENGTH, NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WALGREEN COMPANY]
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NDC 0363-0502-08
Set ID b1229a88-70ac-4c34-9abc-5f3447044eff
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Nasal decongestant 

  • Uses

    • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
      • minor aches and pains
      • nasal congestion 
      • headache
      • sinus congestion and pressure 
    • promotes sinus drainage
    • temporarily reduces fever 
  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen 
    • 3 or more alcoholic drinks every day while using this product 

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical attention right away. 

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients  

    Ask a doctor before use if you have

    • diabetes 
    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin. 

    When using this product

    do not exceed recommended dosage. 

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition. 

    If pregnant or breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

  • Directions

    • do not use more than directed
    • adults and children 12 years and over:
      • take 2 caplets every 4 hours
      • do not take more than 10 caplets in 24 hours
    • children under 12 years: ask a doctor 
  • 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

    corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acid 

  • Questions or comments?

    1-800-426-9391 

  • Principal Display Panel

    Well at
    Walgreens

    NDC 0363-0502-08

    WALGREENS PHARMACIST RECOMMENDEDǂ

    MAXIMUM STRENGTH
    NON-DROWSY

    Wal-Phed® PE

    PE Sinus Headache

    Acetaminophen 325 mg / Pain Reliever / Fever Reducer
    Phenylephrine HCl 5 mg / Nasal Decongestant
    • Relieves sinus headache, sinus pressure & congestion

    24 CAPLETS

    Actual Size

    Compare to Sudafed PE®
    Pressure+Pain active ingredientsǂǂ

    PSEUDOEPHEDRINE FREE

    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

    ǂWalgreens Pharmacist Survey Study, November 2014.

    ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN.
    50844      REV0915D50208

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

    Walgreens
    100%
    SATISFACTION
    GUARANTEED

    walgreens.com   ©2015 Walgreen Co.

    ITEM 501484Walgreens 44-502

    Walgreens 44-502

  • INGREDIENTS AND APPEARANCE
    WAL-PHED PE  MAXIMUM STRENGTH, NON-DROWSY
    acetaminophen, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 44;502
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0502-082 in 1 CARTON06/23/200511/02/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/23/200511/02/2019
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0363-0502)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0502)
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