VICKS SINEX 12 HOUR DECONGESTANT- 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™
SEVERE
Nasal Spray

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure

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
  • do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
  • temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop use and ask a 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 & 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, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, propylene glycol, purified water, sodium citrate

Questions?

1-800-873-8276

Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

VICKS ®

Sinex™

SEVERE

Oxymetazoline HCl-Nasal Decongestant

  • Sinus Congestion & Pressure
  • Fast & Powerful Relief

With

Menthol


12
HOUR


Nasal

Spray

½ FL OZ

(15 ml)

434

VICKS SINEX  12 HOUR DECONGESTANT
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-434
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.0005095 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-434-011 in 1 CARTON04/27/2015
115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/27/201506/01/2021
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2019
Document Id: 8c268cbd-8f51-4080-e053-2995a90a9dc9
Set id: 6d8ee14e-570f-4be6-8231-7bde6d823914
Version: 5
Effective Time: 20190625
 
The Procter & Gamble Manufacturing Company