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  5. Label Information: Sinosil Nasal Decongestant

FDA Label for Sinosil Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    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. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sinosil Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Herbion Pakistan Pvt 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



Xylometazoline HCl 0.1%


Otc - Purpose



Nasal Decongestant


Indications & Usage



Temporarily relieves nasal congestion due to cold, hay fever or other respiratory allergies.


Warnings



Do not exceed recommended dose.


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 use this product for more than 3 days.  Use only as directed.  Frequent or prolonged use may cause nasal congestion to recur or worsen.  If symptoms persist, consult a doctor.
  • This product 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.

Otc - Stop Use



Stop use and ask a doctor if symptoms persist.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, consult your physician before using.


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.


Dosage & Administration



Adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 8 to 10 hours.  Do not give to children under 12 years of age unless directed by a doctor.


Storage And Handling



Store at 20-25 degrees C (68-77 degrees F)


Inactive Ingredient



Disodium edetate, Di-sodium hydrogen phosphate, D.I. Water, Sodium Chloride, Sodium di-hydrogen phosphate, thiomersal

Otc - Questions



Questions or comments?

1-888-654-3724, Monday through Friday, 9am-5pm or www.herbion.com


Package Label.Principal Display Panel



Nasal Decongestant Spray

For temporary decongestion of the nasal mucosa


* Please review the disclaimer below.