Naphcon A

Generic Name: naphazoline hydrochloride and pheniramine maleate
Dosage Form: Eye drops

For the temporary relief of the minor eye symptoms of itching and redness caused by ragweed, pollen, grass, animal dander and hair.

Naphcon A Description

Active: Naphazoline Hydrochloride 0.025%, Pheniramine Maleate 0.3%. Preservative: Benzalkonium Chloride 0.01%. Inactive: Boric Acid, Edetate Disodium 0.01%, Purified Water, Sodium Borate, Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH). The sterile ophthalmic solution has a pH of about 6 and a tonicity of about 270 mOsm/Kg.

DIRECTIONS

Put 1 or 2 drops in the affected eye(s) up to 4 times every day.

Warnings

To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

If solution changes color or becomes cloudy, do not use.

Stop use and ask a doctor if you feel eye pain, changes in vision occur, redness or irritation of the eye(s) gets worse or lasts more than 72 hours.

When using this product, pupils may become enlarged temporarily. Overuse may cause more redness of the eye(s). If you are sensitive to any ingredient in this product, do not use. Do not use this product if you have heart disease, high blood pressure, narrow angle glaucoma or trouble urinating unless directed by a physician. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature. Before using in children under 6 years of age, consult your physician. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison  Control  Center right away. Remove contact lenses before using.

Store at 20°- 25°C (68°- 77°F). Protect from light. Use before the expiration date marked on the carton or bottle.

ALCON LABORATORIES, INC.
FORT WORTH, TX  76134  USA
© 2002, 2004, 2005 Alcon, Inc.

Naphcon A (naphazoline hydrochloride and pheniramine maleate)

PRODUCT INFO Product Code 0065-0085 Dosage Form SOLUTION / DROPS Route Of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength naphazoline hydrochloride (naphazoline) Active 0.25 MILLIGRAM  In 1 MILLILITER pheniramine maleate (pheniramine) Active 3 MILLIGRAM  In 1 MILLILITER benzalkonium chloride Inactive 0.1 MILLIGRAM  In 1 MILLILITER boric acid Inactive   edetate disodium Inactive 0.1 MILLIGRAM  In 1 MILLILITER water Inactive   sodium borate Inactive   sodium chloride Inactive   sodium hydroxide and/or hydrochloric acid Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0065-0085-25 2.5 MILLILITER In 1 BOTTLE, PLASTIC None 2 0065-0085-15 15 MILLILITER In 1 BOTTLE, PLASTIC None 3 0065-0085-30 30 MILLILITER In 1 BOTTLE, PLASTIC None 4 0065-0085-42 5 MILLILITER In 1 BOTTLE, PLASTIC None 5 0065-0085-38 30 MILLILITER In 1 BOTTLE, PLASTIC None

Revised: 08/2006