Drug Facts

Active ingredients

Naphazoline Hydrochloride 0.025%

Pheniramine Maleate 0.3%

Purpose

Redness reliever

Antihistamine

Uses

Temporarily relieves itchy, red eyes due to:

pollen
ragweed
grass
animal hair and dander

Warnings:

For external use only

Do not use if you are sensitive to any ingredient in this product

Ask a doctor before use if you have

heart disease
high blood pressure
narrow angle glaucoma
trouble urinating due to an enlarged prostate gland

When using this product

pupils may become enlarged temporarily
do not touch tip of container to any surface to avoid contamination
replace cap after each use
remove contact lenses before using
do not use if this solution changes color or become cloudy
overuse may cause more eye redness

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day
children under 6 years of age: consult a doctor

Other information

some users may experience a brief tingling sensation
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Boric Acid and Sodium Borate buffer system preserved with Benzalkonium Chloride (0.01%) and Edetate Disodium (0.1%),Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Water for Injection.

Questions?

Call toll-free 1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 17478-065-12

Naphazoline HCl 0.025%

and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE & REDNESS

RELIEVER

Eye Allergy

Relief Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-065-12

Naphazoline HCl 0.025%

and

Pheniramine Maleate 0.3%

Ophthalmic Solution, USP

ANTIHISTAMINE & REDNESS

RELIEVER

Eye Allergy

Relief Eye Drops

► Relives Redness

► Relieves itchy Eyes Due To:

Pollen ● Ragweed ● Grass

Animal Hair & Dander

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Carton Label

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-065
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Naphazoline Hydrochloride (Naphazoline)	Naphazoline Hydrochloride	0.25 mg in 1 mL
Pheniramine Maleate (Pheniramine)	Pheniramine Maleate	3 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid
Sodium Borate
Benzalkonium Chloride
Edetate Disodium
Sodium Hydroxide
Hydrochloric Acid
Water

Packaging
#	Item Code	Package Description
1	NDC:17478-065-12	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202795	01/24/2013

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		063434679	PACK(17478-065), LABEL(17478-065)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(17478-065), ANALYSIS(17478-065), STERILIZE(17478-065)