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Nasal

Shopko Stores Operating Co., LLC

Shopko Nasal Spray Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Nasal Uses

  • •temporarily relieves nasal congestion due to:
  • •common cold
  • •hay fever
  • •upper respiratory allergies
  • •shrinks swollen nasal 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 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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

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

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions?

1-800-719-9260

Principal Display Panel

Compare to Afrin® Original Nasal Spray Active Ingredient

Nasal Spray

Oxymetazoline Hydrochloride 0.05%

Original

Fast Congestion Relief for Allergies and Colds

Nasal Decongestant

12 HOUR RELIEF

1 FL OZ (30 mL)

Nasal

oxymetazoline hydrochloride SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37012-304
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE 0.05 g

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
BENZYL ALCOHOL
EDETATE DISODIUM
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water
SODIUM PHOSPHATE, DIBASIC
sodium phosphate, monobasic

Product Characteristics

Color
WHITE (Translucent)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:37012-304-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-07-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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