FDA.reportPublic FDA data

Wal-Phed PE Pressure plus Pain

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2020-07-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:19:59

Label at a glance#

ProductWal-Phed PE Pressure plus Pain Maximum Strength Non-Drowsy
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and 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 

Dosage and administration

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 

Storage and handling

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 

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Nasal decongestant 

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Liver warning: This product contains acetaminophen. 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 help right away. 

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin. 

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage. 

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Sudafed PE® Pressure + Pain active ingredients††

NDC 0363-5020-08

NON-DROWSY

Wal-Phed® PE

PRESSURE + PAIN

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
PHENYLEPHRINE HCl 5 mg / NASAL DECONGESTANT

MAXIMUM STRENGTH

• Relieves:
Sinus headache, sinus pressure, nasal congestion

• Pseudoephedrine free

24 CAPLETS

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 PE® PRESSURE + PAIN.
50844      REV0417B50208

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

Walgreens
100%  SATISFACTION
            GUARANTEED
walgreens.com   ©2017 Walgreen Co.

44-502
44-502

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-50200363-5020-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
66abe6ee-1905-4357-a096-39cd7a3674c1e3a2601c-6078-4b65-8b61-676f0b09da2f2022-07-16WarningsExact identifier
spl set id: e3a2601c-6078-4b65-8b61-676f0b09da2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.