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SPL v3
SPL
SPL Set ID 22473109-dc9e-45b6-b188-d7d5773f5a14
Route
OPHTHALMIC
Published
Effective Date 2024-10-07
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Alcaftadine (2.5 mg)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Sodium Phosphate, Monobasic Water Sodium Chloride Sodium Hydroxide Hydrochloric Acid

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-10-02

Description

Alcaftadine 0.25%

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Alcaftadine 0.25%

Use

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

Warnings

For external use only

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
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
Active Ingredient

Alcaftadine 0.25%

Other Information
  • For eye use only
  • store at 15° to 25°C (59° to 77°F)
Inactive Ingredients

benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, and water for injection

Questions Or Comments?

(1-866-210-9797

 



Manufactured by:

Gland Pharma Limited,

D.P. Pally, Dundigal Post,

Hyderabad - 500 043, INDIA.



Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA.



Revision: 09/2024

Principal Display Panel

Container Label - 0.25% (3 mL)

NDC 62332-147-03

Alcaftadine Ophthalmic Solution, 0.25%

Antihistamine Eye Drops


Eye Allergy Itch Relief

Sterile

0.10 fl oz (3 mL)





Carton Label - 0.25% (3 mL)

NDC 62332-147-03

ORIGINAL PRESCRIPTION STRENGTH

Alcaftadine Ophthalmic Solution, 0.25%

Antihistamine Eye Drops

ONCE DAILY RELIEF

Eye Allergy Itch Relief

Sterile

30 DAY SUPPLY

0.10 fl oz (3 mL)



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 and Ask Doctor If

you experience any of the following:

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use (USE)

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

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

For external use only

Directions (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
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
Active Ingredient (ACTIVE INGREDIENT)

Alcaftadine 0.25%

Other Information (OTHER INFORMATION)
  • For eye use only
  • store at 15° to 25°C (59° to 77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, and water for injection

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(1-866-210-9797

 



Manufactured by:

Gland Pharma Limited,

D.P. Pally, Dundigal Post,

Hyderabad - 500 043, INDIA.



Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA.



Revision: 09/2024

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Container Label - 0.25% (3 mL)

NDC 62332-147-03

Alcaftadine Ophthalmic Solution, 0.25%

Antihistamine Eye Drops


Eye Allergy Itch Relief

Sterile

0.10 fl oz (3 mL)





Carton Label - 0.25% (3 mL)

NDC 62332-147-03

ORIGINAL PRESCRIPTION STRENGTH

Alcaftadine Ophthalmic Solution, 0.25%

Antihistamine Eye Drops

ONCE DAILY RELIEF

Eye Allergy Itch Relief

Sterile

30 DAY SUPPLY

0.10 fl oz (3 mL)



When Using This Product (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 and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

you experience any of the following:

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching 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.


Advanced Ingredient Data


Raw Label Data

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