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Vicks

Procter & Gamble Manufacturing GmbH

VICKS Sinex VapoSpray 12 HOUR DECONGESTANT Nasal Spray


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

adults & children 6 yrs. & older (with adult supervision) 2 or 3 sprays in each nostril, without tilting your head, 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

benzalkonium chloride, chlorhexidine gluconate, citric acid, disodium EDTA, fragrance, purified water, sodium citrate, sodium hydroxide, tyloxapol

Questions?

1-800-873-8276

www.vicks.com

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

PRINCIPAL DISPLAY PANEL - 15 ml nasal spray container

VICKS®
Sinex®
VapoSpray

Oxymetazoline HCl…Nasal Decongestant

12 HOUR
DECONGESTANT

Nasal Spray

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:64336-682
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE 0.0005055 g

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
chlorhexidine gluconate
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
water
SODIUM CITRATE
SODIUM HYDROXIDE
TYLOXAPOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, SPRAY
2 NDC:64336-682-01 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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