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  5. Label Information: Oxymetazoline Hcl

FDA Label for Oxymetazoline Hcl

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - ASK DOCTOR
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. HOW SUPPLIED

Oxymetazoline Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Seaway Pharma 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.

Otc - Active Ingredient



Active Ingredient: Oxymetazoline HCl 0.05%


Otc - Purpose



Purpose: Nasal Decongestant


Indications & Usage



Uses
Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • shrinks swollen nasal membrances so you can breathe more freely.

Otc - Ask Doctor



Ask a doctor before use if you have

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

Otc - Do Not Use



When using this product:

  • do not use more than directed
  • do not use for more than 3 days. Use only as directed.

Otc - When Using



  • 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 - Pregnancy Or Breast Feeding



Stop use and ask a doctor If symptoms persist.

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 (1-800-222-1222) right away.


Dosage & Administration



Directions

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill not more often 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 backward while spraying. Wipe nozzle clean after use.


Storage And Handling



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

Inactive Ingredient



Inactive Ingredients

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


How Supplied



(pack: 30ml)  NDC# 73414-002-02

(pack: 15ml) NDC# 73414-002-13

Manufactured by:

Seaway Pharma Inc.

Massena, NY 13662


* Please review the disclaimer below.