Naphcon A

Naphazoline hydrochloride and pheniramine maleate · Solution/ Drops · Ophthalmic

Over the counter 1 recall

Active ingredient

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

Purpose

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

Uses

Uses for the temporary relief of redness and itching of the eye(s) due to: ragweed pollen grass animal dander and hair

Warnings

Warnings For external use only

Do not use

Do not use if you are sensitive to any ingredient in this product if this solution changes color or becomes cloudy

Ask a doctor before use

Ask a doctor before use if you have narrow angle glaucoma heart disease high blood pressure trouble urinating

When using this product

When using this product pupils may become enlarged temporarily causing light sensitivity overuse may cause more eye redness remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after each use

Stop use and ask a doctor

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

Keep out of reach of children

Keep out of the 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

Directions adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily children under 6 years: ask a doctor

Inactive ingredients

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

Questions?

Questions? In the U.S. call 1-800-757-9195 or visit www.alcon.com

Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Mar 27, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Naphcon A NDC products (2)

NDCStrength & formLabelerType
50090-0185Naphazoline Hydrochloride .25 mg/mL; Pheniramine Maleate 3 mg/mL
Solution/ Drops
A-S Medication SolutionsNDA
0065-0085Naphazoline Hydrochloride .25 mg/mL; Pheniramine Maleate 3 mg/mL
Solution/ Drops
Alcon Laboratories, Inc.NDA

Naphcon A recalls

Frequently asked questions

What is Naphcon A used for?

Uses for the temporary relief of redness and itching of the eye(s) due to: ragweed pollen grass animal dander and hair

Who makes Naphcon A?

Naphcon A is listed by 2 labelers in the FDA NDC directory, including A-S Medication Solutions, Alcon Laboratories, Inc..

Has Naphcon A been recalled?

The FDA enforcement database lists 1 recall for Naphcon A, most recently D-1313-2022 (class ii): CGMP Deviations: products were stored outside the drug label specifications.