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12 Hour Original Nasal Decongestant

Medically reviewed on January 2, 2018

Dosage form: liquid
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 50mg in 100mL
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-7075

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)

Relabeled By: Preferred Pharmaceuticals Inc.

12 HOUR ORIGINAL NASAL DECONGESTANT 
nasal spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7075(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, UNSPECIFIED FORM 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POVIDONE K30 
BENZALKONIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68788-7075-31 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 finalpart34101/02/2018
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7075)

 
Preferred Pharmaceuticals Inc.

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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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