{"active_ingredient":["Active ingredient (in each 5 mL (teaspoonful) (TSP)) Loratadine 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions adults and children 6 years and older 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours children 2 to under 6 years of age 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) 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":["<table width=\"65%\"><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"60%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">adults and children 6 years and older</td><td styleCode=\"Rrule\">2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">children 2 to under 6 years of age</td><td styleCode=\"Rrule\">1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">children under 2 years of age</td><td styleCode=\"Rrule\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\">consumers with liver or kidney disease</td><td styleCode=\"Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20221129","id":"ee9cc8d4-9b73-202e-e053-2a95a90ae3e1","inactive_ingredient":["Inactive ingredients Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose."],"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"],"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 right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label NDC 0121-0849-10 Children's Loratadine Oral Solution Dye Free/ Alcohol Free/ Sugar Free 10 mg/ 10 mL USUAL DOSAGE: See attached Drug Facts This unit-dose package is not child-resistant. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 10 x 10 mL Unit-Dose Cups Pharmaceutical Associates, Inc. Greenville, SC 29605 T0849100218 R02/18 Principal Display Panel - 10 mL Cup Tray Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions Call 1-800-845-8210"],"set_id":"64112220-8b9b-4871-9d6e-67ee1677acab","spl_product_data_elements":["Childrens Loratadine LORATADINE ANHYDROUS CITRIC ACID BUTYLATED HYDROXYANISOLE GLYCERIN PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE WATER POLYSORBATE 80 LORATADINE LORATADINE grape flavor"],"spl_unclassified_section":["Drug Facts","MANUFACTURED BY Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave Carmel, NY 10512"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information Each teaspoonful (TSP) contains: sodium 1 mg Store between 20° to 25°C (68° to 77°F) Children's Loratadine Oral Solution is a clear, grape flavored solution supplied in the following oral dosage form: NDC 0121-0849-10: 10 mL unit dose cup. NDC 0121-0849-40: Case contains 40 unit dose cups of 10 mL (0121-0849-10) packaged in 4 trays of 10 unit dose cups each."],"storage_and_handling_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"15%\" align=\"left\" valign=\"top\"/><col width=\"85%\" align=\"left\" valign=\"top\"/><tbody><tr><td>NDC 0121-0849-10:</td><td>10 mL unit dose cup.</td></tr><tr><td>NDC 0121-0849-40:</td><td>Case contains 40 unit dose cups of 10 mL (0121-0849-10) packaged in 4 trays of 10 unit dose cups each.</td></tr></tbody></table>"],"version":"4","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}