4 WAY FAST ACTING- phenylephrine hydrochloride spray

4 Way by

Drug Labeling and Warnings

4 Way by is a Otc medication manufactured, distributed, or labeled by Haleon US Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenylephrine Hydrochloride 1%

Purpose

Nasal Decongestant

Uses

temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiratory allergies

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 care 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 4 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 controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride solution, boric acid, purified water, sodium borate

Questions or Comments?

1-855-221-5428

Principal Display

NDC 0067-2086-01

4 way
Fast Acting
Phenylephrine Hydrochloride 1%

Nasal Decongestant

Fast Relief of:

• 1. Nasal Congestion
• 2. Swollen Nasal Membranes
• 3. Sinus Congestion
• 4. Sinus Pressure

Nasal Spray

1 fl oz (29.6 mL)

DO NOT USE IF PERFORATED OVERWRAP PRINTED WITH GSK
LOGO AROUND THE CAP OR BOTTLE IS BROKEN OR MISSING

1-855-221-5428

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2017 GSK group of companies or its licensor.

13183

Made in Canada

INGREDIENTS AND APPEARANCE

4 WAY  FAST ACTING
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-2086
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-2086-01	1 in 1 CARTON	01/01/2010
1		29.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 0067-2086-05	1 in 1 CARTON	01/01/2010	10/31/2013
2		14.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 0067-2086-62	1 in 1 CARTON	01/01/2010	10/31/2013
3		18.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC: 0067-2086-15	1 in 1 CARTON	01/01/2010	01/31/2010
4		37 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	01/01/2010

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