{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "spl_product_data_elements": [ "Loratadine Loratadine Oral LORATADINE LORATADINE GRAPE ASCORBIC ACID GLYCERIN MALTITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SORBITOL SUCRALOSE colorless to light yellow" ], "active_ingredient": [ "Drug Facts Active ingredient (in each 5 mL) Loratadine USP 5 mg" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients." ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "when_using": [ "When using this product do not take more than directed. Taking more than directed may cause drowsiness." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions use only with enclosed dosing cup mL = milliliter adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "storage_and_handling": [ "Other information each 5 mL contains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)" ], "inactive_ingredient": [ "Inactive ingredients artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose." ], "questions": [ "Questions or comments? Call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India" ], "package_label_principal_display_panel": [ "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle) AUROHEALTH NDC 58602-423-11 Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Do not use if carton is opened, or if cap safety seal is broken or missing. Dye-Free Sugar-Free Alcohol Free Indoor & Outdoor Allergies Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL) AUROHEALTH NDC 58602-423-11 # Compare to the active ingredient in children’s Claritin ® Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy,watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)" ], "set_id": "0b86a9fe-db7e-470a-a8fa-d7d4373116ba", "id": "78515214-94d8-4977-aff5-8b9beb60042e", "effective_time": "20250120", "version": "6", "openfda": { "application_number": [ "ANDA208931" ], "brand_name": [ "Loratadine" ], "generic_name": [ "LORATADINE ORAL" ], "manufacturer_name": [ "Aurohealth LLC" ], "product_ndc": [ "58602-423" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LORATADINE" ], "rxcui": [ "692783" ], "spl_id": [ "78515214-94d8-4977-aff5-8b9beb60042e" ], "spl_set_id": [ "0b86a9fe-db7e-470a-a8fa-d7d4373116ba" ], "package_ndc": [ "58602-423-11", "58602-423-24" ], "is_original_packager": [ true ], "unii": [ "7AJO3BO7QN" ] } } ] }