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Preferred Plus 12 Hour Nasal Original

Medically reviewed on March 26, 2018

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 50mg in 100mL
Labeler: Kinray
NDC Code: 61715-048

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
  • Temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have
  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Trouble urinating due to an enlarged prostate gland

When using this product
  • Do not use more than directed
  • Do not use 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 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 persists.

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions
  • Adults and children 6 to under 12 years of age (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 under 6 years of age:  ask a doctor
  • To spray, squeeze bottle quickly and firmly.  Do not tilt head bacward while spraying.  Wipe nozzle clean after use.

Other information
  • Store between 20° to 25°C (68° to 77°F)
  • Retain carton for future reference on full labeling

Inactive ingredients

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

PREFERRED PLUS 12 HOUR NASAL  ORIGINAL
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-048
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
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM ANHYDROUS 
GLYCERIN 
POLYETHYLENE GLYCOL 3350 
POVIDONE 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
WATER 
Packaging
#Item CodePackage Description
1NDC:61715-048-021 BOTTLE, SPRAY in 1 CARTON
1NDC:61715-048-0130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/31/2008
Labeler - Kinray (012574513)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIOperations
Kinray012574513label(61715-048)
Establishment
NameAddressID/FEIOperations
Lee Pharmaceuticals056425432pack(61715-048)
Establishment
NameAddressID/FEIOperations
Samson Pharmaceuticals088169581manufacture(61715-048)

 
Kinray

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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