VICKS SINEX 12 HOUR DECONGESTANT NASAL- 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.

----------

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

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

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.
99495098

PRINCIPAL DISPLAY PANEL - 15 ml Carton

VICKS ®

Sinex ®

12 HOUR
DECONGESTANT
NASAL SPRAY

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 NASAL
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-803
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.0005055 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
TYLOXAPOL (UNII: Y27PUL9H56)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-803-011 in 1 CARTON07/06/201010/08/2017
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/06/201010/08/2017
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2016
Document Id: 40e0e826-94ba-03fe-e054-00144ff88e88
Set id: 828f5e8d-a932-47c8-9725-1c761befc583
Version: 3
Effective Time: 20161109
 
The Procter & Gamble Manufacturing Company