4 WAY MOISTURIZING RELIEF- xylometazoline hydrochloride spray
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Drug Facts

Active ingredient

Xylometazoline hydrochloride 0.1%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:

• a cold • hay fever • upper respiratory allergies

• soothes nasal discomfort caused by dryness

Warnings

Ask a doctor before use if you have

•: heart disease
•: high blood pressure
•: thyroid disease
•: diabetes
•: trouble urinating due to an enlarged prostate gland

When using this product

• do not use more than directed

• do not use 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 an increase in nasal discharge may occur

• infection may spread if this container is used by more than one person

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 and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 8 to 10 hours
•: do not use more than 3 doses in 24 hours
•: children under 12 years of age: ask a doctor

Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other information

•: store at room temperature
•: container is filled to proper level for best spray action
•: non-USP for assay

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate, edetate disodium, hypromellose, monobasic sodium phosphate, purified water, sodium chloride, sorbitol solution

Questions or comments?

1-800-452-0051

Principal Display Panel

NDC 0067-2094-05

4 way®

Nasal Decongestant

Xylometazoline Hydrochloride 0.1%

Moisturizing Relief

NEW!

Fast Relief of:

1.: Nasal Congestion
2.: Discomfort Caused By Dryness
3.: Swollen Nasal Membranes
4.: Sinus Pressure

Nasal Spray

½ fl. Oz. (14.8mL)

DO NOT USE IF PRINTED NOVARTIS BOTTLE OVERWRAP IS BROKEN OR MISSING

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

MADE IN USA

www.4wayspary.com

30566A

4 way moisturizing relief 0.5 fl oz (14.8mL) carton

4 WAY MOISTURIZING RELIEF
xylometazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-2094
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K)	XYLOMETAZOLINE HYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-2094-05	1 in 1 CARTON	01/01/2010	07/27/2017
1		14.8 mL in 1 BOTTLE, SPRAY; 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	01/01/2010	07/27/2017

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 7/2017

Document Id: 208b7a6f-b6dd-4aeb-9f2d-6fb1381bad8b

Set id: e15b44f1-fda7-4140-bdc4-7ce626f2bd03

Version: 2

Effective Time: 20170727

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC