CONTRAINDICATIONS

Hypersensitivity to one or more of the components of this preparation. Do not use in the presence of narrow angle glaucoma or patients predisposed to narrow angle glaucoma.

WARNINGS

Patients under MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug such as Naphazoline HCI. Use in infants and children may result in CNS depression leading to coma and marked reduction in body temperature.

Remove contact lenses to instill Naphcon - A. Wait at least 15 minutes before reinserting lenses.

PRECAUTIONS

General:

For topical eye use only - not for injection. This preparation should be used with caution in patients with severe cardiovascular disease including cardiac arrhythmias, patients with poorly controlled hypertension, patients with diabetes, especially those with a tendency toward diabetic ketoacidosis.

Information for Patients:

To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding area with the dropper tip of the bottle.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

There have been no long-term studies done using naphazoline hydrochloride and/or pheniramine maleate in animals to evaluate carcinogenic potential.

Pregnancy:

Animal reproduction studies have not been conducted with naphazoline hydrochloride and/or pheniramine maleate. It is also not known whether naphazoline hydrochloride and/or pheniramine maleate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphcon - A Ophthalmic Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naphcon - A Ophthalmic Solution is administered to a nursing woman.

PEDIATRIC USE

Use with caution in children under 6 years of age.

ADVERSE REACTIONS

The following adverse reactions may occur: Pupillary dilation, increase in intraocular pressure, systemic effects due to absorption (i.e., hypertension, cardiac irregularities, hyperglycemia). Drowsiness may be experienced by some patients.

DOSAGE

1-2 drops instilled in each eye every 3-4 hours or less frequently, as required to relieve symptoms.

STORAGE

Store at room temperature. Keep bottle tightly closed when not in use. Protect from light and excessive heat.

SUPPLIED

Each Drop-Tainer^® Dispenser contains:

A sterile buffered solution of naphazoline HCI 0.025% and pheniramine maleate 0.3%; preserved with benzalkonium chloride.

Nonmedicinal ingredients: boric acid, sodium chloride, sodium borate, edetate disodium, sodium hydroxide and/or hydrochloric acid, purified water.