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Nasal decongestant by H-E-B

Medically reviewed on September 15, 2017

Dosage form: solution
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05mg in 100mL
Labeler: H-E-B
NDC Code: 37808-832

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 nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Warnings

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product
  • do not exceed recommended dosage
  • 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 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 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 use Pump

  • shake well before use
  • to open the cap, hold the bottle with one hand, use the other hand to press groved area of cap firmly and turn counter closwise
  • line up the grooved line on the pump
  • to spray, hold with thumb at bottom of the bottle andnozzle between fingers. Before using the first time, prime pump by depressing pump firmly several times.
  • insert tip of nozzle into nostril. Pump 2 or 3 times into each nostril and sniff deeply without tilting head.
  • wipe nozzle clean after each use
  • to close the cap, turn unitl it 'clicks'

Other information
  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labelling

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water,

sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

1-800-883-0085

PRINCIPAL DISPLAY PANEL -

NASAL DECONGESTANT 
oxymetazoline hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-832
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
WATER 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
POVIDONE 
Packaging
#Item CodePackage Description
1NDC:37808-832-051 BOTTLE, PUMP in 1 CARTON
115 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2016
Labeler - H-E-B (007924756)

 
H-E-B

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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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