ALCAFTADINE solution/ drops

alcaftadine by

Drug Labeling and Warnings

alcaftadine by is a Otc medication manufactured, distributed, or labeled by Alembic Pharmaceuticals Inc., Gland Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ALCAFTADINE 
alcaftadine solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62332-147
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCAFTADINE (UNII: 7Z8O94ECSX) (ALCAFTADINE - UNII:7Z8O94ECSX)	ALCAFTADINE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62332-147-03	1 in 1 CARTON	10/02/2024
1		3 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209290	10/02/2024

Labeler - Alembic Pharmaceuticals Inc. (079288842)

Establishment
Name	Address	ID/FEI	Business Operations
Gland Pharma Limited		918601238	MANUFACTURE(62332-147)