NASAL- phenylephrine hydrochloride spray 
Kroger Company

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.

----------

Kroger Co. Nasal Spray Drug Facts

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

When using this product

do not use more than directed
do not use for 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 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 and over: 2 or 3 sprays in each nostril not more often than every 4 hours
children under 12 years: 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?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of 4-WAY® FAST ACTING NASAL SPRAY

See side panel

OUR PHARMACIST RECOMMENDED

Fast Acting

Nasal Spray

Phenylephrine Hydrochloride 1%

Nasal Decongestant

FAST RELIEF OF:

Nasal Congestion

Swollen Nasal Membranes

Sinus Congestion

Sinus Pressure

4 HOUR RELIEF

1 FL OZ (30 mL)

648-45-nasal-spray.jpg
NASAL 
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-539
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-539-101 in 1 CARTON02/18/2014
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/18/2014
Labeler - Kroger Company (006999528)

Revised: 3/2021
Document Id: 755fbc57-718d-42d4-9894-45a289c542c5
Set id: 1c3dc4e6-452b-4c84-b53c-426cf9ae8f03
Version: 4
Effective Time: 20210302
 
Kroger Company