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  5. Label Information: Daytime Congestion Pressure And Pain

FDA Label for Daytime Congestion Pressure And Pain

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Daytime Congestion Pressure And Pain 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.

Active Ingredients (In Each Softgel)



Acetaminophen 325 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever/Fever reducer

Nasal decongestant


Uses



  • temporarily relieves symptoms due to the common cold
    • minor aches and pains
    • headache
    • fever
    • nasal congestion
    • sinus congestion & pressure
    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
      • minor aches and pains
      • headache
      • nasal congestion
      • sinus congestion & pressure

Warnings



Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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



  • 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.   

Ask A Doctor Before Use If You Have



  • liver disease       
  • heart disease  
  • high blood pressure            
  • thyroid disease
  • diabetes  
  • trouble urinating due to enlarged prostate gland

Stop Use And Ask A Doctor If



  • 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
  • you get nervous, dizzy or sleepless

Directions



  • take only as directed 
  • do not exceed 4 doses per 24 hrs

    • adults and children 12 yrs & over

         2 softgels with water every 4 hrs

    children 4 to under 12 yrs

         ask a doctor

    children under 4 yrs

         do not use


Other Information



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

Inactive Ingredients



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


Questions Or Comments?



Call toll free: 1-855-215-8180


Principal Display Panel



Daytime Congestion, Pressure & Pain  24 SOFTGELS

NDC 69842-018-04

*Compare to the active ingredients in Vicks® Sinex™ Daytime Congestion, Pressure & Pain


* Please review the disclaimer below.