EQUALINE FAST ACTING- phenylephrine hydrochloride spray 
SUPERVALU INC.

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

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant

Uses

for the temporary relief of 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 exceed recommended dosage

• do not use for more than 3 days. Use only as directed

• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

• the use of this container by more than one person may spread infection

• frequent or prolonged use may cause nasal congestion to recur or worsen

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 of age and over: 2 or 3 sprays in each nostril not more 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 between 20°-25°C (68°-77°F)
container is filled to proper level for best spray action

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate

Questions

1-877-932-7948

IMPORTANT: Keep this carton for future reference on full labeling

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

Distributed By: Supervalu Inc.
Eden Prairie, MN 55344

This product is not manufactured or distributed by Novartis Consumer Health Inc., the owner of the registered trademark 4-Way Fast Acting Nasal Spray.

Principal Display

NDC 41163-728-01

Equaline

Fast Acting

Nasal Spray

Phenylephrine hydrochloride 1%

(nasal decongestant)

fast acting relief of

nasal congestion
sinus congestion
sinus pressure
swollen nasal passages

1 FL OZ (30mL)

Equaline Nasal Spray
EQUALINE  FAST ACTING
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-728
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-728-011 in 1 CARTON
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/30/2014
Labeler - SUPERVALU INC. (006961411)

Revised: 11/2014
Document Id: f0f547dd-892b-4f94-8c63-7f0b2470aa91
Set id: f0f547dd-892b-4f94-8c63-7f0b2470aa91
Version: 1
Effective Time: 20141103
 
SUPERVALU INC.