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Name:Vicks Sinex 12 Hour Decongestant Ultra Fine Mist
Manufacturer:The Procter & Gamble Manufacturing Company
Category:Over-the-counter (OTC) Marketed Drugs


VICKS® Sinex®

VICKS SINEX  12 HOUR DECONGESTANT ULTRA FINE MIST - oxymetazoline hydrochloride spray 
The Procter & Gamble Manufacturing Company

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.

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VICKS®
Sinex®

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

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

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 Carton

VICKS®

Sinex®

12 HOUR
DECONGESTANT
ULTRA FINE MIST

Oxymetazoline HCl...
Nasal Decongestant

Cold & Allergy
Congestion

Sinus Pressure

12
HOUR
RELIEF

Fast Acting
Day/Night Relief

See Drug Facts

1/2 FL OZ
(15 ml)

Principal Display Panel - 15 ml Carton

VICKS SINEX   12 HOUR DECONGESTANT ULTRA FINE MIST
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-802
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline Hydrochloride 0.0005095 g  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-802-01 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 15 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (37000-802-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/06/2010

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 04/2010 The Procter & Gamble Manufacturing Company



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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