NDC Code(s) : 0067-2086-01, 0067-2086-05, 0067-2086-62, 0067-2086-15
Packager : Haleon US Holdings LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

4 Way Phenylephrine hydrochloride SPRAY
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2086
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BORIC ACID(UNII: R57ZHV85D4)
SODIUM BORATE(UNII: 91MBZ8H3QO)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0067-2086-011 in 1 CARTON 01/01/2010
129.6 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product
2NDC:0067-2086-051 in 1 CARTON 01/01/2010
214.8 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product
3NDC:0067-2086-621 in 1 CARTON 01/01/2010
318.5 mL in 1 BOTTLE, SPRAY Type 0: Not a Combination Product
4NDC:0067-2086-151 in 1 CARTON 01/01/2010
437 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 Drug M012 01/01/2010

LABELER - Haleon US Holdings LLC(079944263)

PRINCIPAL DISPLAY PANEL

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.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2020 GSK group of companies or its licensor.

Made in Japan

64810SBC1 Front Carton

4 Way Fast Acting 1fl oz (29.6 ml)