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NDC 00067-2086-01 4 Way 10 mg/mL Details

4 Way 10 mg/mL

4 Way is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenylephrine nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine nasal spray will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 00067-2086-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine Nasal Spray

Product Information

NDC	00067-2086
Product ID	0067-2086_87d7b11c-4227-4073-95e2-1404bfe6d2f2
Associated GPIs	42102050102015
GCN Sequence Number	008062
GCN Sequence Number Description	phenylephrine HCl SPRAY 1 % NASAL
HIC3	Q7D
HIC3 Description	NOSE PREPARATIONS, VASOCONSTRICTORS(OTC)
GCN	34124
HICL Sequence Number	002087
HICL Sequence Number Description	PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	4 Way
Proprietary Name Suffix	Fast Acting
Non-Proprietary Name	Phenylephrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00067-2086-01 (00067208601)

Pricing Information	N/A
NDC Package Code	0067-2086-01
Billing NDC	00067208601
Package	1 BOTTLE, SPRAY in 1 CARTON (0067-2086-01) / 29.6 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2010-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8fc41c7-4425-41b8-b1c6-eb22ac054734 Details

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
•: thyroid disease
•: diabetes
•: high blood pressure
•: 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
•: use only as directed
•: temporary discomfort such as burning, stinging, sneezing, or an increase in 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 care professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, 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 PRINTED NECKBAND IS BROKEN OR MISSING

1-855-221-5428

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

Made in Japan

64810SBC1 Front Carton

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

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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2010

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

Revised: 2/2021

Document Id: 87d7b11c-4227-4073-95e2-1404bfe6d2f2

Set id: a8fc41c7-4425-41b8-b1c6-eb22ac054734

Version: 7

Effective Time: 20210226