FDA Label for Major Nasal Decongestant

View Indications, Usage & Precautions

Major Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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 Ingredient



Oxymetazoline 0.05%


Purpose



Nasal Decongestant


Uses



Temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely

Ask A Doctor Before Use If You Have



  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate 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


If Pregnant Or Breast-Feeding



ask a health professional before use.


Keep Out Of The Reach Of Children



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


Directions



  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • 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.

Other Information



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

Inactive Ingredients



Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic


Principal Display Panel



Major ® No Drip Nasal Mist NDC 0904-7427-30
Nasal Spray Oxymetazoline HCL 0.05%
12 hour Nasal Spray
1 FL OZ (30 mL)


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