Naphazoline HCI And Pheniramine Maleate NAPHAZOLINE HYDROCHLORIDE PHENIRAMINE MALEATE ALTAIRE PHARMACEUTICALS INC. FDA Approved Uses: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.
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Route
OPHTHALMIC
Applications
ANDA078208
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Naphazoline Hydrochloride (0.027%) Pheniramine Maleate (0.315%)
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.01% boric acid edetate disodium 0.1% hypromellose purified water sodium borate and sodium chloride.
Quantities
15 ml
Treats Conditions
Uses Temporarily Relieves Itching And Redness Caused By Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
MZ1131787D NYW905655B
Packaging

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); IL15; OL15

Package Descriptions
  • 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)
  • IL15
  • OL15

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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.
Purpose

Purpose Redness Reliever Antihistamine

Do Not Use

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.

When Using

Remove contact lenses before using.

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

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

Questions

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


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