FDA Label for Alcaftadine
View Indications, Usage & Precautions
Alcaftadine Product Label
The following document was submitted to the FDA by the labeler of this product Alembic Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
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)
* Please review the disclaimer below.
