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← See all 12 Hour Original Nasal Decongestant brands

12 Hour Original Nasal Decongestant

Dosage form: liquid
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 50mg in 100mL
Labeler: Faria LLC dba Sheffield Pharmaceutical
NDC Code: 11527-140

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 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.

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.

  • 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

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

Principal display panel- Bottle

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 -Carton

Lee

Relieves Conmgestion

Nasal Spray  original 12 hour relief

  • Oxymetazoline HCL Nasal Solution
  • Nasal Decongestant

1 FL OZ (30 ml)

12 HOUR ORIGINAL NASAL DECONGESTANT 
nasal spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-140
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE50 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 
GLYCERIN 
PROPYLENE GLYCOL 
DISODIUM EDTA-COPPER 
SODIUM PHOSPHATE, MONOBASIC 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
POVIDONE K29/32 
BENZALKONIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:11527-140-551 BOTTLE, SPRAY in 1 CARTON
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/FEIOperations
Faria LLC dba Sheffield Pharmaceutical151177797manufacture(11527-140)

 
Faria LLC dba Sheffield Pharmaceutical

← See all 12 Hour Original Nasal Decongestant brands

Medically reviewed on Aug 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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