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  5. Label Information: Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief

FDA Label for Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief

View Indications, Usage & Precautions

Table of Contents

    1. NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. NIGHTTIME SINUS CONGESTION AND COUGH RELIEF ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    3. PURPOSES
    4. USES
    5. NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. NIGHTTIME  SINUS CONGESTION AND COUGH RELIEF WARNINGS
    12. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    13. WHEN USING THIS PRODUCT
    14. NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF DIRECTIONS
    15. NIGHTTIME SINUS CONGESTION AND COUGH RELIEF DIRECTIONS
    16. NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF OTHER INFORMATION
    17. NIGHTTIME SINUS CONGESTION AND COUGH RELIEF OTHER INFORMATION
    18. NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF INACTIVE INGREDIENTS
    19. NIGHTTIME SINUS CONGESTION AND COUGH RELIEF INACTIVE INGREDIENTS
    20. NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF
    21. NIGHTTIME SINUS CONGESTION AND COUGH RELIEF
    22. PRINCIPAL DISPLAY PANEL

Non Drowsy Daytime And Nighttime Sinus Congestion And Cough Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Non Drowsy Daytime Sinus Congestion And Cough Relief Active Ingredients (In Each Softgel)



Acetaminophen 325 mg  

Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg


Nighttime Sinus Congestion And Cough Relief Active Ingredients (In Each Softgel)



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


Purposes



Non Drowsy DAYTIME Sinus Congestion and Cough Relief

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Nighttime Sinus Congestion and Cough Relief

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses



Non Drowsy DAYTIME Sinus Congestion and Cough Relief

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • nasal and sinus congestion
    • temporarily reduces fever

      • NIghttime Sinus Congestion and Cough Relief

      • temporarily relieves these symptoms due to a cold or flu:
        • minor aches and pains
        • headache
        • nasal and sinus congestion
        • cough
        • sore throat
        • runny nose
        • sneezing
        • temporarily reduces fever

Non Drowsy Daytime Sinus Congestion And Cough Relief Warnings



Liver warning

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

  • more than 4000 mg of Acetaminophen 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

    • 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.

    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



  • 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   

Otc - When Using



When using this product do not exceed recommended dosage 


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.


Nighttime  Sinus Congestion And Cough Relief Warnings



Liver warning

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

  • more than 4000 mg of Acetaminophen 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

    • 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.

    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 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

Non Drowsy Daytime Sinus Congestion And Cough Relief Directions



  • 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

Nighttime Sinus Congestion And Cough Relief Directions



  • 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

Non Drowsy Daytime Sinus Congestion And Cough Relief Other Information



  • store at room temperature. Avoid excessive heat.

Nighttime Sinus Congestion And Cough Relief Other Information



  • store at room temperature. Avoid excessive heat.

Non Drowsy Daytime Sinus Congestion And Cough Relief Inactive Ingredients



FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol sorbitan, titanium
dioxide


Nighttime Sinus Congestion And Cough Relief Inactive Ingredients



D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
glycol, povidone, propylene glycol, purified water, sorbitol sorbitan,
sodium hydroxide†, titanium dioxide
†may contain this ingredient


Non Drowsy Daytime Sinus Congestion And Cough Relief



Questions or comments?1-888-333-9792


Nighttime Sinus Congestion And Cough Relief



Questions or comments?1-888-333-9792


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