{"active_ingredient":["ACTIVE INGREDIENT Alcaftadine 0.25%"],"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"],"dosage_and_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"],"effective_time":"20241007","id":"64d45e8d-158b-42f2-84aa-14fc849eaf0e","inactive_ingredient":["INACTIVE INGREDIENTS benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, and water for injection"],"indications_and_usage":["USE temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander"],"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."],"openfda":{"application_number":["ANDA209290"],"brand_name":["alcaftadine"],"generic_name":["ALCAFTADINE"],"is_original_packager":[true],"manufacturer_name":["Alembic Pharmaceuticals Inc."],"nui":["N0000000190","N0000175587"],"package_ndc":["62332-147-03"],"pharm_class_epc":["Histamine-1 Receptor Antagonist [EPC]"],"pharm_class_moa":["Histamine H1 Receptor Antagonists [MoA]"],"product_ndc":["62332-147"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["1000085"],"spl_id":["64d45e8d-158b-42f2-84aa-14fc849eaf0e"],"spl_set_id":["22473109-dc9e-45b6-b188-d7d5773f5a14"],"substance_name":["ALCAFTADINE"],"unii":["7Z8O94ECSX"]},"package_label_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) alcaftadine-label alcaftadine-carton"],"purpose":["PURPOSE Antihistamine"],"set_id":"22473109-dc9e-45b6-b188-d7d5773f5a14","spl_product_data_elements":["alcaftadine alcaftadine ALCAFTADINE ALCAFTADINE BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM PHOSPHATE, MONOBASIC WATER SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID"],"spl_unclassified_section":["OTHER INFORMATION For eye use only store at 15° to 25°C (59° to 77°F)","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"],"stop_use":["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"],"version":"3","warnings":["WARNINGS For external use only"],"when_using":["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"]}