1. Home
  2. Labeler Index
  3. Cardinal Health 110,inc
  4. 70000-0676
  5. Label Information: Leader Nasal Decongestant

FDA Label for Leader Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF THE REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS

Leader Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110,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.

Drug Facts




Active Ingredient



Oxymetazoline HCL 0.05%


Purpose



Nasal Decongestant 


Uses



Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely

Warnings




Ask A Doctor Before Use If You Have



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

When Using This Product



Do not use more than directed

  • do not use for more than three days, Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur.
  • use of this container by more than one person may spread infection.

Stop Use And Ask A Doctor If



Symptoms persist 


Keep Out Of The Reach Of Children



if swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other Information



store between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling


Inactive Ingredients



benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water


* Please review the disclaimer below.