SINOSIL NASAL DECONGESTANT- xylometazoline hcl 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.

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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

When using this product

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

SINOSIL  NASAL DECONGESTANT
xylometazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44237-007
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K) XYLOMETAZOLINE HYDROCHLORIDE.015 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
THIMEROSAL (UNII: 2225PI3MOV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44237-007-1515 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/09/2011
Labeler - Herbion Pakistan Pvt Ltd (645482936)
Registrant - Herbion Pakistan Pvt Ltd (645482936)
Establishment
NameAddressID/FEIBusiness Operations
Herbion Pakistan Pvt Ltd645482936manufacture

Revised: 2/2011
Document Id: f6aa67eb-5aa4-4ea8-806b-f47da3e4d5f9
Set id: 0b1f1890-044a-4bc2-bf87-648bdc479a13
Version: 1
Effective Time: 20110209
 
Herbion Pakistan Pvt Ltd