Vicks ® Sinex™ Moisturizing

Drug Details [pdf]

VICKS SINEX 12 HOUR NASAL DECONGESTANT ULTRA FINE MIST MOISTURIZING- 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™

Moisturizing

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

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)

432

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64336-172
Route of Administration	NASAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 64336-172-01	1 in 1 CARTON	04/27/2015	07/10/2018
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/27/2015	07/10/2018

Labeler - Procter & Gamble Manufacturing GmbH (333608813)

Revised: 4/2023

Document Id: f93d4cd6-92f6-43ed-e053-6294a90a29e8

Set id: cfe0e0a6-cec8-b027-e053-2995a90a96aa

Version: 3

Effective Time: 20230413