Label: SEVERE NASAL- oxymetazoline hydrochloride 0.05% spray

  • NDC Code(s): 73492-715-15
  • Packager: ALAINA HEALTHCARE PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

  • PURPOSE

    Active ingredient                                                                                                                                              Purpose

    Oxymetazoline hydrochloride 0.05% ............................................................................................... Nasal decongestant
  • INDICATIONS & USAGE

    Uses

    temporarily relieves

    • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
    • sinus congestion and pressure
  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not exceed recommended dosage
    • 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.
    • temporary discomfort such as burning, stinging, sneezing or increased 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults & children 6 years & older (with adult 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 2 to under 6 years: ask a doctor.
    • Children under 2 years: do not use.
  • STORAGE AND HANDLING

    Other information -do not exceed 25°C

  • Inactive ingredients

    aloe barbadensis leaf extract, benzalkonium chloride, disodium EDTA, polyethylene glycol, PVP, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphste monobasic

  • Principal Display Panel

    SEVERE Nasal Spray
    Oxymetazoline HCl 0.05 %
    Nasal Decongestant
    SUPER-FINE Moisturizing MIST
    - Helps relieve sinus congestion & pressure
    - Soothing aloe
    0.5 FL OZ (15mL)

    oxymetazoline-container.jpg
  • INGREDIENTS AND APPEARANCE
    SEVERE NASAL 
    oxymetazoline hydrochloride 0.05% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73492-715
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73492-715-151 in 1 CARTON09/15/2023
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/15/2023
    Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALAINA HEALTHCARE PRIVATE LIMITED858720927manufacture(73492-715)
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