SINOSIL NASAL DECONGESTANT- xylometazoline hcl spray

Sinosil by

Drug Labeling and Warnings

Sinosil by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Xylometazoline HCl 0.1%

PURPOSE

Nasal Decongestant

INDICATIONS & USAGE

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

WARNINGS

Do not exceed recommended dose.

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
  

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.
  

STOP USE

Stop use and ask a doctor if symptoms persist.

PREGNANCY OR BREAST FEEDING

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

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

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

Nasal Decongestant Spray

For temporary decongestion of the nasal mucosa

INGREDIENTS AND APPEARANCE

SINOSIL  NASAL DECONGESTANT
xylometazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-007
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K)	XYLOMETAZOLINE HYDROCHLORIDE	.015 mL  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
THIMEROSAL (UNII: 2225PI3MOV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-007-15	15 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/09/2011

Labeler - Herbion Pakistan Pvt Ltd (645482936)

Registrant - Herbion Pakistan Pvt Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan Pvt Ltd		645482936	manufacture