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  5. Label Information: Leader Severe Congestion Nasal

FDA Label for Leader Severe Congestion Nasal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. INDICATIONS & USAGE
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. DOSAGE & ADMINISTRATION
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Severe Congestion Nasal Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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                                                                   Purpose

Oxymetazoline hydrochloride 0.05% ......................................Nasal decongestant

Otc - Purpose



Uses

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

Warnings



Warnings

For external use only


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 - When Using



When using this product

  • do not use more than directed
  • do not use 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.

Indications & Usage



Directions

  • adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours.  Don not exceed 2 doses in any 24-hour period.
  • children under 6 years of age : ask a doctor.  To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril.  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use.

Storage And Handling



Other information

  • store between 15o to 25oC (59o and 77oF)
  • retain carton for future reference on full labeling

Inactive Ingredient



Inactive ingredients

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

Dosage & Administration



DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3467651

www.myleader.com

1-800-200-6313

Made in Korea


Package Label.Principal Display Panel



image of carton label - LeaderNasalSevere

image of carton label - LeaderNasalSevere

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