VICKS SINEX SEVERE CONGESTION- oxymetazoline hydrochloride spray

Vicks Sinex SEVERE CONGESTION by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Keep out of reach of children.

OVERDOSAGE

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• adults & children 6 years & 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 years: ask a doctor
• children under 2 years: do not use

Other information

• store at no greater than 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

SPL UNCLASSIFIED SECTION

Note: This container is properly filled when approximately half full. Air space equal to one half of volume is necessary to propel the fine spray.

Only selected information is listed on the bottle label. Keep this container for future reference.

TAMPER EVIDENT: CARTON SEALED FOR YOUR PROTECTION.

SPL UNCLASSIFIED SECTION

MADE IN GERMANY

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

VICKS ®

Sinex™

SEVERE CONGESTION

Oxymetazoline HCl Nasal Decongestant

NASAL SPRAY

• Fast Relief for Sinus, Allergy & Nasal Congestion
• Sinus Pressure

12 HOUR RELIEF

0.5 FL OZ
(15 ml)

INGREDIENTS AND APPEARANCE

VICKS SINEX SEVERE CONGESTION 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64336-002
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.0005 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: 64336-002-01	1 in 1 CARTON	02/27/2026
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 Drug	M012	02/27/2026

Labeler - Procter & Gamble Manufacturing GmbH (333608813)