FDA Label for Day And Night Severe Sinus Congestion And Cough Maximum Strength

Day Severe Sinus Congestion & Coughactive Ingredients (In Each Softgel)

Acetaminophen 325 mg 

Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Night Sever Sinus Congestion  & Coughactive Ingredients (In Each Softgel)

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg

Purposes

Day Severe Sinus Congestion & Cough

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Night Sever Sinus Congestion & Cough

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

Day Severe Sinus Congestion & Cough

• temporarily relieves these symptoms due to a cold or flu:
  • nasal congestion
  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • cough
  • sore throat
  • helps clear nasal passages and shrinks swollen membranes
  • temporarily reduces fever

  Night Sever Sinus Congestion & Cough

  • temporarily relieves these symptoms due to a cold or flu:
    • nasal congestion
    • sinus congestion and pressure
    • headache
    • minor aches and pains
    • cough
    • sore throat
    • runny nose
    • sneesing
    • helps clear nasal passages and shrinks swollen membranes
    • temporarily reduces fever
    
    

Day Severe Sinus Congestion & Coughwarnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock
  

  If a skin or general allergic 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
• in children under 12 years of age  
• 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
• in children under 12 years of age  

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

• 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.

• nervousness, dizziness, or sleeplessness occurs  
• 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.

• nervousness, dizziness, or sleeplessness occurs  

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Night Sever Sinus Congestion & Coughwarnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock
  

  If a skin or general allergic 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 to sedate children.

Ask A Doctor Or Pharmacist Before Use If You Are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When Using This Product

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

Day Severe Sinus Congestion & Coughdirections

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Night Sever Sinus Congestion & Coughdirections

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Day Severe Sinus Congestion & Coughother Information

• Store at room temperature 15°-30°C (59°-86°F).

Night Sever Sinus Congestion & Coughother Information

• Store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat.

Day Severe Sinus Congestion & Coughinactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white ink

Night Sever Sinus Congestion & Coughinactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white ink

Day Severe Sinus Congestion & Coughquestions Or Comments?

Call toll free: 1-855-215-8180

Night Sever Sinus Congestion & Coughquestions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

CVS Day and Night Severe Sinus Congestion and Cough 20ct

NDC 69842-158-08

*Compare to the active ingredients in Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day & Night Liquid Gels