Sinosil Nasal Decongestant: Package Insert and Label Information

SINOSIL NASAL DECONGESTANT- xylometazoline hydrochloride spray
Herbion Pakistan Pvt Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Xylometazoline HCl 0.1%

Nasal Decongestant

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

Do not exceed recommended dose.

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 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 and ask a doctor if symptoms persist.

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

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

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.

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


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

Questions or comments?

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

Nasal Decongestant Spray

For temporary decongestion of the nasal mucosa

Sinosil carton
(click image for full-size original)
SINOSIL NASAL DECONGESTANT
xylometazoline hcl spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44237-007
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
XYLOMETAZOLINE HYDROCHLORIDE (XYLOMETAZOLINE) XYLOMETAZOLINE HYDROCHLORIDE .015 mL in 15 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
WATER
SODIUM CHLORIDE
THIMEROSAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44237-007-15 15 mL in 1 BOTTLE, SPRAY None
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 Operations
Herbion Pakistan Pvt Ltd 645482936 manufacture

Revised: 02/2011 Herbion Pakistan Pvt Ltd

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