{"active_ingredient":["Active Ingredient (in each 5 mL teaspoonful) Cetirizine hydrochloride, USP 5mg"],"ask_doctor":["Ask a doctor before use if you have • liver or kidney disease. Your doctor should determine if you need a different dose • hives that are an unusual color, look bruised or blistered • hives that do not itch"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"dosage_and_administration":["Directions • use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["<table cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"100%\"> <col width=\"49%\"/> <col width=\"49%\"/> <tbody> <tr> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 6 years and over  </paragraph> </td> <td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.  </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>adults 65 years and over  </paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.  </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children under 6 years of age  </paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>ask a doctor  </paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>consumers with liver or kidney disease  </paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>ask a doctor   </paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191216","id":"8b463d63-760a-4e54-8d78-86973b0d5eba","inactive_ingredient":["Inactive ingredients artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose"],"indications_and_usage":["Uses relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring."],"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 toll-free number 1-800-222-1222."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC 57664-246-31 6 years&older Children’s Cetirizine Hydrochloride 1mg / mL Oral Solution, USP antihistamine HIVES Relief 24 hour Relief of ITCHING Due to Hives Dosing Cup Included Dosing cup should be washed and left to air dry after each use Do not use if carton is opened, or if seal of bottle is broken or missing 6 years and older Grape Syrup 4 fl. oz. (120 mL) drug"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: ask a health professional before use."],"purpose":["Purpose Antihistamine"],"set_id":"328285dd-127a-4515-8898-dfde4ac20251","spl_product_data_elements":["Cetirizine Hydrochloride HIVES Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ACETIC ACID GLYCERIN METHYLPARABEN WATER PROPYLENE GLYCOL PROPYLPARABEN SODIUM ACETATE SUCROSE Colorless to slightly yellow"],"spl_unclassified_section":["Drug Facts","Do not use to prevent hives from any known cause such as: • foods • insect stings • medicines • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. • If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.","Other information Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)","Questions or comments? call toll-free 1-800-818-4555 weekdays Dist. by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, Michigan 48202 Mfg. by: SUN Pharmaceutical Industries, Inc. Bryan, Ohio 43506 6027L01 Iss: 09/11"],"stop_use":["Stop use and ask doctor if • an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve after 3 days of treatment • the hives have lasted more than 6 weeks"],"version":"2","warnings":["Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: • trouble swallowing • dizziness or loss of consciousness • swelling of tongue • swelling in or around mouth • trouble speaking • drooling • wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times."],"when_using":["When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery"]}