1. Home
  2. Labeler Index
  3. Chain Drug Marketing Association Inc.
  4. 63868-464
  5. Label Information: Daytime Sinus Relief And Nighttime Sinus Relief

FDA Label for Daytime Sinus Relief And Nighttime Sinus Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS FOR NIGHTTIME SINUS (IN EACH SOFTGEL)
    2. ACTIVE INGREDIENTS FOR DAYTIME SINUS (IN EACH SOFTGEL)
    3. PURPOSES
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Daytime Sinus Relief And Nighttime Sinus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association 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 For Nighttime Sinus (In Each Softgel)



Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Active Ingredients For Daytime Sinus (In Each Softgel)



Acetaminophen 325 mg
Phenylephrine hydrochloride 5 mg


Purposes



Nighttime Sinus Relief

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Daytime Sinus Relief

Pain reliever/Fever reducer

Nasal decongestant


Uses



  • temporarily relieves symptoms due to the common cold
    • minor aches and pains
    • headache
    • fever
    • runny nose and sneezing (Nighttime only)
    • nasal congestion
    • sinus congestion & pressure
    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies
      • minor aches and pains
      • headache
      • runny nose and sneezing (Nighttime only)
      • itching of the nose or throat, and itchy, watery eyes (Nighttime only)
      • nasal congestion
      • sinus congestion & pressure

Warnings



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

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. 
  • to make a child sleep (Nighttime only)    

Ask A Doctor Before Use If You Have



  • liver disease      
  • heart disease              
  • thyroid disease
  • diabetes  
  • high blood pressure  
  • glaucoma (Nighttime only)             
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)  
  • trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking sedatives or tranquilizers (Nighttime only)             
  • taking the blood thinning drug warfarin

When Using This Product



  • do not use more than directed, in addition when using Nighttime Sinus and Congestion:
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If



  • pain or nasal congestion gets worse or last 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  

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 & for children even if you do not notice any signs or symptoms.


Directions



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

    • Age

    Daytime Sinus

    Nighttime Sinus

    adults and children 12 years and over

    2 softgels with water every 4 hours

    2 softgels with water every 4 hours

    children 4 to under 12 years

    ask a doctor

    ask a doctor

    children under 4 years

    do not use

    do not use


Other Information



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

Inactive Ingredients



Nighttime Sinus: FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Daytime Sinus: FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink


Questions Or Comments?



Call 248-449-9300


Principal Display Panel



CDMA Daytime Sinus Relief and Nighttime Sinus Relief 48 SOFTGELS

NDC 63868-464-48

Compare to the active ingredients in Vicks® QlearQuilTM Daytime Sinus & Congestion and Nighttime Sinus & Congestion*

Carton Label 1 - CDMA06 00 1

Carton Label 1 - CDMA06 00 1


* Please review the disclaimer below.