FDA Label for Sinus Pe Head Congestion And Flu Severe

Active Ingredients (In Each Caplet)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

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

Warnings

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

• 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 
• 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

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, 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,

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 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 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

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

Inactive Ingredients

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?

1-800-426-9391

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CVSHealth_®

Compare to the active ingredients in Sudafed PE® Head Congestion + Flu Severe*

Daytime
Non-Drowsy
Sinus PE
Head Congestion + 
Flu Severe

ACETAMINOPHEN - Pain reliever. Fever reducer
DEXTROMETHORPHAN HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant

Relieves:
Sinus pressure, Headache,
Sore throat, Cough, Chest congestion

24 COATED CAPLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IS 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® Head Congestion + Flu Severe.
50844     REV0820D54608

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CVS 44-546 - cvs 44 546 ppch 1