Label: SINUFRIN NEILMED- oxymetazoline hydrochloride spray

  • NDC Code(s): 13709-231-04, 13709-231-07, 13709-231-12
  • Packager: NeilMed Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • Active Ingredients

    0.05% Oxymetazoline Hydrochloride

  • Uses

    temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

  • Warnings

    Do not exceed recommended dosage. 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.

  • Warnings

    Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.

  • Directions for Dosing

    Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor.

  • Other Information

    Store between 20 to 40 °C (68 to 104 °F)
    Retain carton for future reference on full labeling

  • Warnings

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

  • Warnings

    Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may
    cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high
    blood pressure, thyroid disease or diabetes unless directed by a doctor. Adult males with prostate disease, do not use this product.

  • Other Information

    Keep head in an upright position for use. Do not tilt head backward while spraying. Wipe nozzle clean after each use.

  • Warnings

    Stop using this product for more than 3 consecutive days. Stop and ask your doctor if symptoms of nasal congestion persist after using 3 consecutive days.

  • Warnings

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

  • Uses

    temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies.

  • Inactive Ingredients

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

  • Principal Display label

    SinuFrin bottle label

  • Box label

    image description

  • INGREDIENTS AND APPEARANCE
    SINUFRIN  NEILMED
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-231
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE7.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-231-0715 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)07/15/2012
    2NDC:13709-231-0415 mL in 1 BOX; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)07/15/2012
    3NDC:13709-231-121 in 1 CARTON04/21/2021
    330 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2012
    Labeler - NeilMed Pharmaceuticals Inc (799295915)
    Registrant - NeilMed Pharmaceuticals Inc (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc799295915manufacture(13709-231)
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