Naphazoline Hydrochloride and Pheniramine Maleate

Akorn, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients
• Purpose
• Naphazoline Hydrochloride and Pheniramine Maleate Uses
• Warnings:
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Naphazoline Hydrochloride and Pheniramine Maleate Other information
• Inactive ingredients
• Questions?

FULL PRESCRIBING INFORMATION

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.)