Drug Facts

Drug Facts
SPL v16
SPL
SPL Set ID 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58
Route
OPHTHALMIC
Published
Effective Date 2023-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.25 mg) Pheniramine (3 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Borate Sodium Chloride Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
NDA Active Since 1994-06-08 Until 2021-11-30

Description

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


Medication Information

Description

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

Uses

for the temporary relief of redness and itching of the eye(s) due to:

  • ragweed
  • pollen
  • grass
  • animal dander and hair
Section 55105-1
Active ingredients Purpose
Naphazoline hydrochloride 0.025% Redness reliever
Pheniramine maleate 0.3% Antihistamine
Warnings

For external use only

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
Do Not Use
  • if you are sensitive to any ingredient in this product
  • if this solution changes color or becomes cloudy
Questions?

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

Other Information
  • store at 20°-25°C (68°-77°F)
  • protect from light
Inactive Ingredients

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

Principal Display Panel

$3 Coupon Inside



NAPHCON A®



Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%



Ophthalmic Solution



Redness Reliever and Antihistamine



RELIEVES ITCHING & REDNESS




EYE DROPS



STERILE 15 mL (0.5 FL OZ)



TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.



Actual Size



Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.



SEE COUPON INSIDE



ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, TX 76134 USA



Alcon



LOT:

EXP.:



300055595-0122


EYE ALLERGY RELIEF



NAPHCON A®



Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%



Ophthalmic Solution



Redness Reliever and Antihistamine 



RELIEVES ITCHING & REDNESS



EYE DROPS



CLINICALLY PROVEN



STERILE 15 mL (0.5 FL OZ)



Alcon



Active ingredients:
Naphazoline

Active ingredients: Naphazoline Hydrochloride 0.025%, Pheniramine Maleate 0.3%.



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



DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor.



WARNINGS: See Drug Facts on outer carton for Warnings. Remove contact lenses before using. To avoid contamination, do not touch tip of container to any surface.



To open: push cap down while turning. Replace cap after each use.



Keep this and all drugs out of reach of children.



TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase. Store at 20° - 25°C (68° - 77°F). Protect from light.



ALCON LABORATORIES, INC.

FORT WORTH, TX 76134 USA 



LOT:                                  EXP:



300035727-0320

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 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 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.

Ask A Doctor Before Use If You Have
  • narrow angle glaucoma
  • heart disease
  • high blood pressure
  • trouble urinating

Structured Label Content

Uses

for the temporary relief of redness and itching of the eye(s) due to:

  • ragweed
  • pollen
  • grass
  • animal dander and hair
Section 55105-1 (55105-1)
Active ingredients Purpose
Naphazoline hydrochloride 0.025% Redness reliever
Pheniramine maleate 0.3% Antihistamine
Warnings

For external use only

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
Do Not Use (Do not use)
  • if you are sensitive to any ingredient in this product
  • if this solution changes color or becomes cloudy
Questions?

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

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

$3 Coupon Inside



NAPHCON A®



Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%



Ophthalmic Solution



Redness Reliever and Antihistamine



RELIEVES ITCHING & REDNESS




EYE DROPS



STERILE 15 mL (0.5 FL OZ)



TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase.



Actual Size



Combines a redness reliever and an antihistamine for the temporary relief of itchy, red eyes.



SEE COUPON INSIDE



ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, TX 76134 USA



Alcon



LOT:

EXP.:



300055595-0122


EYE ALLERGY RELIEF



NAPHCON A®



Naphazoline Hydrochloride 0.025% and Pheniramine Maleate 0.3%



Ophthalmic Solution



Redness Reliever and Antihistamine 



RELIEVES ITCHING & REDNESS



EYE DROPS



CLINICALLY PROVEN



STERILE 15 mL (0.5 FL OZ)



Alcon



Active ingredients:
Naphazoline

Active ingredients: Naphazoline Hydrochloride 0.025%, Pheniramine Maleate 0.3%.



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



DIRECTIONS: Put 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor.



WARNINGS: See Drug Facts on outer carton for Warnings. Remove contact lenses before using. To avoid contamination, do not touch tip of container to any surface.



To open: push cap down while turning. Replace cap after each use.



Keep this and all drugs out of reach of children.



TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with the word “Alcon” around the neck. Do not use if seal is damaged or missing at time of purchase. Store at 20° - 25°C (68° - 77°F). Protect from light.



ALCON LABORATORIES, INC.

FORT WORTH, TX 76134 USA 



LOT:                                  EXP:



300035727-0320

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 If (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 the 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • narrow angle glaucoma
  • heart disease
  • high blood pressure
  • trouble urinating

Advanced Ingredient Data


Raw Label Data

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