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  5. Label Information: No Drip Severe Nasal Mist

FDA Label for No Drip Severe Nasal Mist

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING
    8. KEEP OUT OF THE REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL PANEL 0.5 FLOZ BOTTLE
    13. PRINCIPAL DISPLAY PANEL- CARTON LABEL

No Drip Severe Nasal Mist Product Label

The following document was submitted to the FDA by the labeler of this product Sheffield Pharmaceuticals Llc. 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 Hydrochloride 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° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Inactive Ingredients



Benzalkonium Chloride, Camphor, Cellulose Gum, Disodium EDTA, Disodium Phosphate, Eucalyptol, Glycerin, Menthol, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, PEG-6, Povidone, Propylene Glycol, Sodium Phosphate, Water (purified)


Principal Panel 0.5 Floz Bottle



Sheffield         NDC 11527-145-55

No Drip Severe Nasal Mist 

Nasal Spray 

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 30 ml (1.01 FLOZ)


Principal Display Panel- Carton Label



Sheffield  No Drip Severe Nasal Mist    NDC 11527-145-55

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt  30ml (1.01FLOZ)


* Please review the disclaimer below.