Label: SINUFRIN QUICK RELIEF DECONGESTANT- sinufrin spray

  • NDC Code(s): 13709-325-01
  • Packager: Neilmed pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • Drug Facts Active Ingredients

    Oxymetazoline hydrochloride 0.04%

  • Purpose

    Nasal Decongestant

  • Uses:

    • Temporarily relieves nasal congestion due to:
    • Common cold
    • Hay fever
    • Upper respiratory allergies
    • Temporarily relieves sinus congestion and pressure
    • Shrinks swollen nasal membranes so you can breathe more freely
  • Warnings

    Ask a doctor before use if you have

    • Heart disease
    • High blood pressure
    • Diabetes
    • Thyroid disease
    • Trouble urinating due to an enlarged prostate gland
  • When using this product

    • Do not use more than directed
    • Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
    • Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
    • Use of this container by more than one person may spread infection.
  • Warnings

    ​Stop use and ask a doctor if symptoms persist

  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.

  • Warnings

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

  • Directions

    • Adults and children 6 to under 12 years of age (with adult supervision): 3 or 4 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    • Children under 6 years of age: ask a doctor To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.
  • OTHER SAFETY INFORMATION

    Other Information

    • Store between 68° F (20° C) and 86° F (30° C)
    • Retain carton for future reference on full labeling
  • Inactive Ingredients

    Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.

  • Principal Display Panel

    Sinufrin spray

  • INGREDIENTS AND APPEARANCE
    SINUFRIN QUICK RELIEF DECONGESTANT 
    sinufrin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-325
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE (UNII: 8VLN5B44ZY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-325-011 in 1 CARTON12/11/2023
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/11/2023
    Labeler - Neilmed pharmaceuticals Inc. (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-325)
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