Label: 12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid

  • NDC Code(s): 11527-140-55
  • Packager: Sheffield Pharmaceuticals LLC
  • 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 November 18, 2021

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
    • sinusitis
    • upper respiroty allergies
    • Shribnk swollen membranes so you can breathemore 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 onyl 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 thna one person may spread infection.
  • stop use and ask a doctor if

    symptoms persist.

  • PREGNANCY

    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.

  • DOSAGE & ADMINISTRATION

    • 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
  • Other information

    • store between 20° and 25°C (68° to 77°F)
    • retain carton for future reference on full labeling
  • Inactive Ingredients:

    benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

  • Principal display panel- Bottle

    Sheffield Pharmaceutical          NDC 11527-140-55

    Original Nasal Spray 

    Oxymetazoline HCL 0.05%

    12hour relief of Nasal congestion due to:

    • common cold
    • hay fever
    • sinusitis
    • upper respiratory allergies

    30 mL  (1.01 FL OZ)

    Nasal Spray Front label bottle 1 OZ

    Principal display panel- Bottle back label

    Principal display panel- Bottle back label

    Principal display panel- Bottle back label

  • Principal display panel -Carton

    Sheffield Pharmaceuticals                           NDC 11527-140-55

    Original Nasal Spray

    Oxymetazoline HCL 0.05%

    12 hour relief of Nasal congestion due to:

    • common cold
    • hay fever
    • sinusititus 
    • upper respiratory allerigies

    30 mL (1.01 FL OZ)

    Principal display panel -Carton

  • INGREDIENTS AND APPEARANCE
    12 HOUR ORIGINAL NASAL DECONGESTANT 
    nasal spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-140
    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
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-140-551 in 1 CARTON05/30/2014
    130 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 finalpart34105/30/2014
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-140)