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  5. Label Information: Nasal

FDA Label for Nasal

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 15 ML CARTON

Nasal Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor 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 Facts


Active Ingredient



Oxymetazoline Hydrochloride 0.05%


Purpose



Nasal Decongestant


Uses



  • temporary relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely

Otc - Ask Doctor



Ask a doctor before use if you have

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

Otc - When Using



When using this product: 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 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



  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
  • do not exceed 2 doses within any 24-hour 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


Storage And Handling



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

Inactive Ingredients



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


Questions Or Comments?



1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel - 15 Ml Carton



WE CARE

12 Hour NASAL SPRAY
DECONGESTANT

oxymetazoline hydrochloride 0.05%

Compare to active ingredient of Afrin


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