12 HOUR NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ALTAIRE PHARMACEUTICALS INC.]

12 HOUR NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ALTAIRE PHARMACEUTICALS INC.]
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NDC 59390-036-13
Set ID 91426486-d052-4f21-b128-c483bb720f6c
Category HUMAN OTC DRUG LABEL
Packager Altaire Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    12 HOUR NASAL SPRAY

    Oxymetazoline Hydrochloride 0.05% Nasal Spray

    Drug Facts

  • Active ingredients

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    ● temporarily relieves nasal congestion due to:

          ● common cold

          ● hay fever

          ● other respiratory allergies

    ● temporarily relieves sinus congestion and pressure

    ● shrinks swollen nasal membranes so you can breathe more freely

  • Warnings

    ● 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

  • Stop use and ask a doctor if

    symptoms persist

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • 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 adults supervision): 2 or 3 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 spray, squeeze bottle quickly and firmly. Do not tilt heard backward while spraying. Wipe nozzle clean after use.

  • Other information

    ● store between 20° to 30°C (36° to 86°F)

    ● retain carton for future reference on full labeling

    ● see bottle or box for Lot Number and Expiration Date

  • Inactive ingredients

    Benzalkonium chloride, disodium edetate, disodium phosphate, monosodium phosphate, purified water, sodium chloride, sorbitol

  • Questions or comments?

    Call (631) 722-5988 9am-5pm EST Monday-Friday.

    Tamper evident

    Do not use if imprinted seal of bottle cap is torn, missing or broken.

    Manufactured by

    Altaire Pharmaceuticals, Inc. Aquebogue, NY

  • PRINCIPAL DISPLAY PANEL

    NDC 59390-036-13
    12 hour nasal spray

    Oxymetazoline Hydrochloride 0.05%
    ½ fl oz (15
    mL)

    PRINCIPAL DISPLAY PANEL
NDC 59390-036-13
12 hour nasal spray
Oxymetazoline Hydrochloride 0.05%
½ fl oz (15 mL)

  • INGREDIENTS AND APPEARANCE
    12 HOUR NASAL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59390-036
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59390-036-131 in 1 CARTON
    115 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/01/2001
    Labeler - Altaire Pharmaceuticals Inc. (786790378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Altaire Pharmaceuticals Inc.786790378MANUFACTURE(59390-036)