Alcaftadine ALCAFTADINE GLAND PHARMA LIMITED FDA Approved Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
FunFoxMeds bottle
Substance Alcaftadine
Route
OPHTHALMIC
Applications
ANDA209706

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Alcaftadine 0.25%
Inactive Ingredients
Inactive ingredients benzalkonium chloride 0.005% edetate disodium monobasic sodium phosphate sodium chloride sodium hydroxide and/or hydrochloric acid water for injection
Strengths
0.25 %
Quantities
3 ml
Treats Conditions
Use Temporarily Relieves Itchy Eyes Due To Pollen Ragweed Grass Animal Hair And Dander

Identifiers & Packaging

Container Type BOTTLE
UNII
7Z8O94ECSX
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Container Label - 0.25% (3 mL) NDC-68083-649-01 Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops 0.10 fl oz (3 mL) Sterile Container Carton - 0.25% (3 mL) ORIGINAL PRESCRIPTION STRENGTH NDC-68083-649-01 3 mL Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed 40 DAY SUPPLY Sterile 0.10 fl oz (3 mL) Container Carton - 0.25% (3 mL) - Twin Pack ORIGINAL PRESCRIPTION STRENGTH TWIN PACK NDC-68083-649-02 3 mL Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed 80 DAY SUPPLY Sterile Two 3 mL bottles (0.10 fl oz each) alcaftadine-spl-container-label alcaftadine-spl-carton-label-mono-pack alcaftadine-spl-carton-label-twin-pack

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL Container Label - 0.25% (3 mL) NDC-68083-649-01 Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops 0.10 fl oz (3 mL) Sterile Container Carton - 0.25% (3 mL) ORIGINAL PRESCRIPTION STRENGTH NDC-68083-649-01 3 mL Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed 40 DAY SUPPLY Sterile 0.10 fl oz (3 mL) Container Carton - 0.25% (3 mL) - Twin Pack ORIGINAL PRESCRIPTION STRENGTH TWIN PACK NDC-68083-649-02 3 mL Alcaftadine Ophthalmic Solution 0.25% Antihistamine Eye Drops ONCE DAILY RELIEF Eye Allergy Itch Relief Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed 80 DAY SUPPLY Sterile Two 3 mL bottles (0.10 fl oz each) alcaftadine-spl-container-label alcaftadine-spl-carton-label-mono-pack alcaftadine-spl-carton-label-twin-pack

Overview

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Indications & Usage

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Dosage & Administration

Directions adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor

Warnings & Precautions
Warnings For external use only
Purpose

Purpose Antihistamine

Do Not Use

Do not use ■ if solution changes color or becomes cloudy ■ if you are sensitive to any ingredient in this product ■ to treat contact lens related irritation

When Using

When using this product ■ do not touch tip of container to any surface to avoid contamination ■ remove contact lenses before use ■ wait at least 10 minutes before reinserting contact lenses after use ■ do not wear a contact lens if your eye is red

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following: ■ eye pain ■ changes in vision ■ increased redness of the eye ■ itching that worsens or lasts for more than 72 hours

Keep Out of Reach of Children

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.


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