Label: SINOSIL NASAL DECONGESTANT- xylometazoline hcl spray

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated February 9, 2011

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  • 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

    Sinosil carton

  • INGREDIENTS AND APPEARANCE
    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
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