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Vicks

Procter & Gamble Manufacturing GmbH

VICKS Sinex VapoSpray MOISTURIZING 12 HOUR DECONGESTANT Ultra Fine Mist


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Vicks Uses

temporarily relieves nasal congestion due to

  • colds
  • hay fever
  • upper respiratory allergies

Warnings

Ask a doctor before use if you have

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

When using this product

  • do not exceed recommended dosage
  • use of this container by more than one person may spread infection
  • temporary burning, stinging, sneezing, or increased nasal discharge may occur
  • frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask a doctor if

  • symptoms persist for more than 3 days

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

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.

adults & children 6 yrs. & older (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 24 hours.
children 2 to under 6 yrs. ask a doctor
children under 2 yrs. do not use

Vicks Other information

  • store at room temperature

Inactive ingredients

acesulfame potassium, aloe vera, benzalkonium chloride, chlorhexidine gluconate, citric acid, disodium EDTA, fragrance, purified water, sodium citrate, sodium hydroxide, sorbitol, tyloxapol

Questions?

1-800-873-8276

www.vicks.com

Made in Germany
Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 15 ml mist container

VICKS®
Sinex®
VapoSpray

Oxymetazoline HCl…
Nasal Decongestant

MOISTURIZING
12 HOUR
DECONGESTANT

Ultra Fine
Mist

With Soothing
Vicks Vapors

See
Drug Facts

1/2 FL OZ
(15 ml)

Vicks

Vicks

OXYMETAZOLINE HYDROCHLORIDE SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64336-685
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE 0.000512 g

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
Aloe Vera Leaf
benzalkonium chloride
chlorhexidine gluconate
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
water
SODIUM CITRATE
SODIUM HYDROXIDE
sorbitol
TYLOXAPOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, PUMP
2 NDC:64336-685-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-06-25


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Be sure to consult your doctor before taking any medication!
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