Drugplain

Alcaftadine 2.5 mg/mL

Alcaftadine · SOLUTION/ DROPS · Gland Pharma Limited

No Recall History
Plain English

Alcaftadine is a solution/ drops containing alcaftadine at 2.5 mg/mL, taken ophthalmic. Manufactured by Gland Pharma Limited.

Key Facts

Brand Name
Alcaftadine
Generic Name
Alcaftadine
NDC Code (Product)
68083-649
Manufacturer
Gland Pharma Limited
Strength
2.5 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA209706
Drug Class
Histamine-1 Receptor Antagonist [EPC]
Marketing Start
03/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2 reports
abdominal pain1 reports
activities of daily living impaired1 reports
agitation1 reports
condition aggravated1 reports
death1 reports
dermatitis1 reports
drug dose omission1 reports
dry eye1 reports
epilepsy1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

WARNINGS For external use only

Frequently Asked Questions

What is Alcaftadine used for?

Alcaftadine contains Alcaftadine. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Alcaftadine a controlled substance?

Alcaftadine is not classified as a controlled substance by the DEA.

What is the generic name for Alcaftadine?

The generic name for Alcaftadine is Alcaftadine. There are 3 other brand versions of Alcaftadine.

What is the NDC code for Alcaftadine 2.5 mg/mL?

The NDC (National Drug Code) for Alcaftadine 2.5 mg/mL is 68083-649, listed by Gland Pharma Limited.

Product NDC

68083-649

Package NDC

68083-649-01

Other Alcaftadine Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)