pressure and pain sinus relief PE

Manufacturer
Rite Aid Corporation | LNK International, Inc.
Effective date
2022-06-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:59:20

Label at a glance#

Productpressure and pain sinus relief PE NON-DROWSY
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take 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

see end flap for expiration date and lot number  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)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

  • blisters
  • rash
  • skin reddening

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

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

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

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, cough, 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
  • cough comes back or occurs with rash or headache that lasts. 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 take 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

  • see end flap for expiration date and lot number 
  • 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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 


Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE
AID
®
PHARMACY

*Compare to the active ingredients in SUDAFED PE® PRESSURE + PAIN + COLD

pressure & pain
sinus relief PE

acetaminophen 325 mg, dextromethorphan HBr 10 mg
guaifenesin 100 mg, phenylephrine HCl 5 mg

pain reliever/fever reducer, cough suppressant 
expectorant & nasal decongestant

NON-DROWSY
relieves:
sinus pressure and congestion
sinus headache, sore throat,
chest congestion and cough 

ACTUAL SIZE

20 CAPLETS

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark
SUDAFED PE® PRESSURE + PAIN + COLD.   50844       REV0918D54609

SATISFACTION 
RITE AID®
GUARANTEE

IF YOU'RE NOT
SATISFIED, WE'LL
HAPPILY REFUND
YOUR MONEY.

DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

Rite Aid 44-546
Rite Aid 44-546

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-546111822-5461-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
fcde3fec-73d8-42f7-a714-8694b0718b37d6461a3a-e1aa-470e-9293-8353159d69762022-06-14WarningsExact identifier
spl id: fcde3fec-73d8-42f7-a714-8694b0718b37
spl set id: d6461a3a-e1aa-470e-9293-8353159d6976

Reported adverse events (FAERS/openFDA)#

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