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Assured Nasal Relief by United Exchange Corp.

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05mg in 100mL
Labeler: United Exchange Corp.
NDC Code: 65923-387

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.

Active ingredient                                                 Purpose

Oxymetazoline HCl..............................................Nasal decongestant

Uses

temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • temprarily relievves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinated due to an enlarged prostate gland

When using this product

  • do not use more than directed
  • do not use 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 persist

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 to 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 8 years of age: ask a doctor.

Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tiliting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

Other information

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

Inactive ingredients benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, disodium EDTA, distilled water, monobasic sodium phosphate, PEG 1450, PVP K30

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

ASSURED NASAL RELIEF 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-387
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BENZYL ALCOHOL 
SODIUM PHOSPHATE, DIBASIC DIHYDRATE 
EDETATE DISODIUM 
WATER 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
POLYETHYLENE GLYCOL 1450 
POVIDONE K30 
Packaging
#Item CodePackage Description
1NDC:65923-387-051 BOTTLE, SPRAY in 1 BOX
115 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2013
Labeler - United Exchange Corp. (840130579)

Revised: 10/2016
 
United Exchange Corp.

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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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