WAL-PHED PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY]

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  • WAL-PHED PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY]

WAL-PHED PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY]
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NDC 0363-0192-08
Set ID 57d23d57-2e55-4c2d-ad09-f523afc62e13
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)(Daytime only)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 100 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant 

  • Active ingredients (in each caplet) (Nighttime only)

    Acetaminophen 325 mg
    Diphenhydramine HCl 25 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Antihistamine
    Nasal decongestant 

  • Uses(Daytime only)

    • temporarily relieves these symptoms due to the common cold:
      • headache
      • nasal congestion
      • sore throat
      • cough
      • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily reduces fever
  • Uses(Nighttime only)

    • temporarily relieves these common cold and flu symptoms:
      • runny nose and sneezing
      • minor aches and pain
      • sore throat
      • headache
      • nasal congestion
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • with other drugs containing acetaminophen
    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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. 
    • with any other drug containing diphenhydramine, even one used on skin (Nighttime only)
    • for children under 12 years of age (Nighttime only)

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • liver disease
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • cough that occurs with too much phlegm (mucus) (Daytime only)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
    • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
    • glaucoma (Nighttime only)

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers (Nighttime only)

    When using this product

    • do not exceed recommended dosage
    • be careful when driving a motor vehicle or operating machinery (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • excitability may occur, especially in children (Nighttime only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
    • avoid alcoholic beverages (Nighttime only)

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, cough, or nasal congestion gets worse or lasts more than 7 days (Daytime only)
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts (Daytime only)

    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.

    If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

  • Directions(Daytime only)

    • 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
  • Directions(Nighttime only)

    • do not use more than directed
    • adults and children 12 years and over
      • take 2 caplets every 4 hours
      • do not take more than 12 caplets 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients (Daytime only)

    corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide 

  • Inactive ingredients(Nighttime only)

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin 

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    DAY & NIGHT PACK   NDC 0363-0192-08

    Walgreens

    DAYTIME • NON-DROWSY

    Wal-Phed® PE
    PRESSURE + PAIN + COLD

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
    DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
    GUAIFENESIN / EXPECTORANT
    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    MULTI-SYMPTOM

    •Relieves sore throat, head
    & body aches, sinus
    pressure & congestion,
    cough & chest
    congestion

    ACTUAL SIZE

    12 CAPLETS

    Compare to Sudafed PE®
    Day & Night active ingredients††

    NIGHTTIME

    Wal-Phed® PE
    COLD & FLU

    ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
    DIPHENHYDRAMINE HCl / ANTIHISTAMINE
    PHENYLEPHRINE HCl / NASAL DECONGESTANT

    MULTI-SYMPTOM

    •Relieves sore throat, head
    & body aches, runny
    nose, sinus pressure
    & congestion 

    ACTUAL SIZE

    12 CAPLETS

    TOTAL 24 CAPLETS

    DOES NOT CONTAIN GLUTEN

    †Walgreens Pharmacist Survey
    †This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Day & NIght.

    50844 ORG051754654408

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

    PHARMACIST Walgreens RECOMMENDED†
    Health expertise you rely on, quality you trust.

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2017 Walgreen Co.

    Walgreens 44-544546

    Walgreens 44-544546

  • INGREDIENTS AND APPEARANCE
    WAL-PHED  PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME
    acetaminophen, dextromethorphan hbr, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0192
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0192-081 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product02/22/2007
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK 12 
    Part 1 of 2
    WAL-PHED  PE, DAYTIME
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;546
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 FINALpart34102/22/2007
    Part 2 of 2
    WAL-PHED  PE, NIGHTTIME
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 44;544
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 FINALpart34109/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/22/2007
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0363-0192)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0363-0192)
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