EQUALINE FAST ACTING- phenylephrine hydrochloride spray

Equaline by

Drug Labeling and Warnings

Equaline by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

EQUALINE  FAST ACTING
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-728
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-728-01	1 in 1 CARTON
1		30 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	10/30/2014

Labeler - SUPERVALU INC. (006961411)