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Naphazoline HCI 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, USP


OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Naphazoline Hydrochloride (0.027%)

Pheniramine Maleate (0.315%)


OTC - PURPOSE SECTION

Purpose

Redness Reliever

Antihistamine


INDICATIONS & USAGE SECTION

Uses: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.


WARNINGS SECTION

Warnings: if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Do not use in children under 6 years of age unless directed by a physician. If this solution changes color or becomes cloudy, do not use. Overuse of this product may produce increased redness of the eye.

If you are sensitive to any ingredient in this product, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.


OTC - DO NOT USE SECTION

Do not use if imprinted seal on cap is torn, broken or missing, or if imprinted seals on top ad bottom flaps are not intact and completely legible.


OTC - ASK DOCTOR SECTION

Ask a doctor before use if  you have

  • heart disease
  • high blood pressure
  • trouble urinating due to enlarged prostrate gland
  • narrow angle glaucoma

OTC - WHEN USING SECTION

Remove contact lenses before using.


OTC - STOP USE SECTION

Stop use and ask a doctor if you experience: eye pain, changes in vision, redness or irritation of the eye that worsens or persists for more than 72 hours. Overuse of this product may produce increased redness of the eye. Pupils may become enlarged temporarily. You may experience a brief tingling sensation after putting drops in eyes.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.


DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 6 years of age and older: instill 1 or 2 drops in affected eye(s) up to 4 times daily.

Children under 6 years: ask a doctor.


STORAGE AND HANDLING SECTION

Store at room temperature 20 degrees - 25 degrees C ( 68 degrees - 77 degrees F).

Protect from light.


SPL UNCLASSIFIED SECTION

Use before expiration date marked on the carton or bottle.

Available in 15mL NDC 59390-177-13 and 30 mL NDC 59390-177-18


INACTIVE INGREDIENT SECTION

Inactive ingredients

benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate, and sodium chloride.


OTC - QUESTIONS SECTION

Questions or comments

Call (631) 722-5988 9am - 5pm EST Monday - Friday


SPL UNCLASSIFIED SECTION

Manufactured by:

Altaire Pharmaceuticals, Inc.

Aquebogue, N.Y. 11931


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALTAIRE Pharmaceuticals, Inc.

Aquebogue, N.Y. 11931

Naphazoline HCI 0.027%

and

Pheniramine Maleate 0.315%

Ophthalmic Solution, USP

Eye Allergy Relief

With Antihistamine To Relieve Itching

Itching and Redness Reliever Eye Drops

0.5 Fl. OZ. (15mL)


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL