Alcaftadine Solution/ Drops
FDA Label NDC 62332-147

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alembic Pharmaceuticals Inc. for the product Alcaftadine (NDC 62332-147). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Alcaftadine 0.25%

Purpose

Antihistamine

Use

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

Warnings

For external use only

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 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.

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

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)


Alcaftadine-label (Alcaftadine Label)

Alcaftadine-label (Alcaftadine Label)


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)


Alcaftadine-carton (Alcaftadine Carton)

Alcaftadine-carton (Alcaftadine Carton)

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