VICKS SINEX 12 HOUR NASAL DECONGESTANT ULTRA FINE MIST MOISTURIZING- oxymetazoline hydrochloride spray

Vicks Sinex by

Drug Labeling and Warnings

Vicks Sinex by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. 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. 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, 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

acesulfame potassium, aloe, benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, purified water, sodium citrate, sorbitol.

Questions?

1-800-873-8276

SPL UNCLASSIFIED SECTION

Dist. by
Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

VICKS ®

Sinex™

MOISTURIZING

Ultra Fine Mist

Oxymetazoline HCl-Nasal Decongestant

• Fast Sinus Congestion & Pressure Relief
• Powerful Vicks Vapors
• Soothing Aloe

12
HOUR

½ FL OZ
(15 ml)

INGREDIENTS AND APPEARANCE

VICKS SINEX  12 HOUR NASAL DECONGESTANT ULTRA FINE MIST MOISTURIZING
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-432
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALOE (UNII: V5VD430YW9)
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)
SORBITOL (UNII: 506T60A25R)

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: 37000-432-01	1 in 1 CARTON	04/27/2015
1		15 mL in 1 BOTTLE, PUMP; 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	04/27/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)