Label: MAXIMUM STRENGTH NASAL DECONGESTANT- oxymetazoline spray liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 23, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredient
    Oxymetazoline Hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    Tempoarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • upper respiroty allergies
    • temporaily relieves sinus congestion and pressure
    • Shrinks swollen membranes so you can breathe more freely
  • Warnings

  • Ask a Doctor before use if you have

    • heart diease
    • high blood pressure
    • diabetes
    • thyiod diease
    • trouble urinating due to enlarged rostate gland.
  • When using this product

    • Do not use more than directed
    • do not use for more than three 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 the reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
    • Wipe nozzle clean after use.
    • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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° and 25°C (68° to 77°F)
    • retain carton for future reference on full labeling
  • Inactive Ingredients

    Benzalkonium Chloride Solution, Benzyl Alcohol, Camphor, Edetate Sodium, Eucalyptol, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

  • Principal Panel 0.5 FLOZ Bottle

    Principal Panel 0.5 FLOZ Bottle

    CVS Health    Severe Congestion

    Maxium Strength

    Nasal Spray 

    Oxymetazoline HCL 0.05%

    12 hour Nasal Spray

    Net Wt 0.5 FLOZ (15ml)

    Principal Panel 0.5 FLOZ Bottle

    Principal Panel 0.5 FLOZ Bottle

    Principal display panel- Bottle back label

    Principal display panel- Bottle back labelPrincipal display panel- Bottle back labelPrincipal display panel- Bottle back label

  • Principal display panel -Carton

    CVS Health Severe Congestion

    Maxium Strength

    Nasal Spray

    Oxymetazoline HCL 0.05%

    12 hour Nasal Spray

    Net Wt 0.5 FLOZ (15ml)

    Principal display panel -Carton

    Principal display panel -Carton

    Principal display panel -Carton

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH NASAL DECONGESTANT 
    oxymetazoline spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-316
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE50 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-316-511 in 1 CARTON08/30/2018
    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 finalpart34108/30/2018
    Labeler - CVS Health (062312574)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceutical LLC151177797manufacture(69842-316)