12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]

12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [FARIA LLC DBA SHEFFIELD PHARMACEUTICAL]
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NDC 11527-140-55
Set ID cea0ce76-ae75-4484-a7c2-ff1086e9d8b0
Category HUMAN OTC DRUG LABEL
Packager Faria LLC dba Sheffield Pharmaceutical
Generic Name
Product Class
Product Number
Application Number PART341
  • 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 INGREDIENT

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

  • Principal display panel- Bottle

    image description

    Lee

    Relieves Conmgestion

    Nasal Spray original 12 hour relief

    Oxymetazoline HCL Nasal SolutionNasal Decongestant

    1 FL OZ (30 ml)

    Principal display panel- Bottle back label

    Principal display panel- Bottle back label

  • Principal display panel -Carton

    Lee

    Relieves Conmgestion

    Nasal Spray  original 12 hour relief

    • Oxymetazoline HCL Nasal Solution
    • Nasal Decongestant

    1 FL OZ (30 ml)

    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/30/2014
    Labeler - Faria LLC dba Sheffield Pharmaceutical (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Faria LLC dba Sheffield Pharmaceutical151177797manufacture(11527-140)

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