Vicks Sinex Severe VapoCOOL Ultra Fine Mist 12 Hour spray

Vicks Sinex Severe VapoCOOL by

Drug Labeling and Warnings

Vicks Sinex Severe VapoCOOL by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufacturing GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VICKS SINEX SEVERE VAPOCOOL ULTRA FINE MIST 12 HOUR- oxymetazoline hydrochloride spray 
Procter & Gamble Manufacturing GmbH

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 VapoCOOL Ultra Fine Mist 12 Hour 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

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, inset 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

• do not exceed 25ºC

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

MADE IN GERMANY
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

VICKS ®

Sinex™

SEVERE

Oxymetazoline HCl: Nasal Decongestant

ULTRA FINE MIST

CLEARS NASAL CONGESTION FAST!

VapoCOOL

½ FL OZ

(15 ml)

VICKS SINEX SEVERE VAPOCOOL  ULTRA FINE MIST 12 HOUR
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64336-400
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.0005095 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64336-400-01	1 in 1 CARTON	12/20/2018
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/20/2018	05/01/2020

Labeler - Procter & Gamble Manufacturing GmbH (333608813)

Revised: 12/2022

Document Id: ef537234-1993-1aae-e053-2a95a90a230d

34390-5

Set id: d09d0803-dbcf-659c-e053-2a95a90a9e6a

Version: 2

Effective Time: 20221208