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  5. Label Information: Breaze Nasal Sinus Colds And Allergies

FDA Label for Breaze Nasal Sinus Colds And Allergies

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - ASK DOCTOR
    6. OTC - DO NOT USE
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTION OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE CARTON

Breaze Nasal Sinus Colds And Allergies Product Label

The following document was submitted to the FDA by the labeler of this product Samson Pharmaceuticals, 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.

Other



DRUG FACT

Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA

Visit our website at
www.samson.pharmaceutical.com
Made in USA


Active Ingredient



Oxymetazoline hydrochloride, 0.05%


Purpose



Nasal Decongestant


Uses



  • ♦Temporarily relieves nasal congestion due to:
    • ♦Common cold. Hay fever. Sinusitis
    • ♦Upper respiratory allergies
    • ♦Shrinks swollen nasal membranes so you can breathe more freely

Otc - Ask Doctor



Ask a doctor before use if you have

  • ♦High blood pressure
  • ♦Heart disease
  • ♦Diabetes
  • ♦Thyroid diseases
  • ♦Trouble urinating due to enlarged prostate gland

Otc - Do Not Use



Do not use more than directed

  • ♦Do not use for more than 3 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

Otc - Stop Use



Stop use and ask a doctor if symptoms persist


Otc - Pregnancy Or Breast Feeding



If pregnant or breast- feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adult & children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in age nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 –hr period.

Children under 6 years of age: ask a doctor. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.


Other Information



  • ♦Store between 20C to 25C (68 to 77F).
  • ♦Retain carton for future reference on full labeling.

Inactive Ingredients



Benzalkonium Chloride, Eucalyptus Globulus (Eucaplyptus) Leaf Oil, Camphor, Menthol, Editate Disodium, Sodium Phosphate Dibasic, Polysorbate 80, Sodium Phosphate Monobasic, Propylene Glycol, Water (Aqua).


Question Or Comments?



1-888-995-9935


Principal Display Panel - 30 Ml Bottle Carton



Breaze®

MADE IN THE U.S.A.
WITH PRIDE

Relieves Congestion

Nasal
Spray

Sinus
Colds & Allergies

12 Hour Relief

* Please review the disclaimer below.