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Wal-Phed PE, Multi-Symptom, Daytime, Nighttime

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 100mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Walgreen Company
NDC Code: 0363-0192

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.

Walgreens 44-544546-08-H

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   NDC0363-0192-08

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 44-544546-08

WAL-PHED  PE, MULTI-SYMPTOM, DAYTIME, NIGHTTIME
acetaminophen, dextromethorphan hbr, guaifensin, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0192
Packaging
#Item CodePackage Description
1NDC:0363-0192-081 KIT in 1 PACKAGE, COMBINATION
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;546
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code44;544
Contains    
Packaging
#Item CodePackage Description
112 TABLET, FILM COATED in 1 BLISTER PACK
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/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0192)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0363-0192)

Revised: 10/2017
 
Walgreen Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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