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Nasal

Preferred Pharmaceuticals, Inc

MAJOR Soothing - 12 Hour NASAL DECONGESTANT Spray


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Nasal Uses

  • for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • shrinks swollen 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 urinating due to enlarged prostate gland

When using this product

  • do not exceed recommended dosage
  • do not use for more than 3 days. Use only as directed.
  • may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection
  • frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask 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 within any 24-hour period
  • children under 6 years of age: consult a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

Nasal Other information

  • store between 20° to 25° C (68° to 77° F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

PRINCIPAL DISPLAY PANEL - 30 mL

NDC 68788-9155-3

MAJOR®

Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

REGULAR

oxymetazoline
hydrochloride
0.05%

RELIEVES
CONGESTION
FAST

Compare to
active ingredient
of Afrin®

1 FL.OZ.
(30 mL)

Nasal

Nasal

Oxymetazoline Hydrochloride SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9155(NDC:0904-5711)
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE 5 g

Inactive Ingredients

Ingredient Name Strength
water
benzalkonium chloride
EDETATE DISODIUM
propylene glycol
BENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC
sodium phosphate, monobasic
povidone
HYDROCHLORIC ACID
POLYETHYLENE GLYCOL 1450

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9155-3 30 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-03-17


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Be sure to consult your doctor before taking any medication!
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