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  5. Label Information: Nazal

FDA Label for Nazal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. OTHER SAFETY INFORMATION
    13. INACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nazal Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. 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 ingredients  
Naphazoline hydrochloride 0.05%


Otc - Purpose



Purpose    Nasal decongestant


Indications & Usage



Uses for the temporary relief of nasal congestion due to the common cold, hay fever, or associated with sinusitis


Warnings



Warnings
For external use only


Otc - Do Not Use



Do not use
■for more than 3 days
■in children under 12 years of age because it may cause sedation if swallowed


Otc - Ask Doctor



Ask a doctor before use if you have
■heart disease
■high blood pressure
■thyroid disease  ■diabetes
■difficulty in urination due to enlargement of the prostate gland


Otc - When Using



When using this product
■do not exceed recommended dosage
■if may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
■the use of this container by more than one person may spread infection
■use only as directed
■frequent or prolonged use may cause nasal congestion to recur or worsen


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 our of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions
Adults and children 12 years of age and older - 1 or 2 sprays in each nostril not more often than every 6 hours
Children under 12 years of age -  do not give unless directed by a doctor


Other Safety Information



Other information  
■container is filled to proper level for best spray action


Inactive Ingredient



Inactive ingredients
benzalkonium chloride, citric acid, dibasic potassium phosphate, fragrance, monobasic potassium phosphate, simethicone, sodium chloride, water


Package Label.Principal Display Panel



nazalPDP.jpg

nazalcart.jpg


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