{"active_ingredient":["Active ingredient (in each chewable tablet) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy"],"dosage_and_administration":["Directions find right dose on chart below chew or crush tablets completely before swallowing; do not swallow tablets whole take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (yr) Dose (chewable tablets) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)"],"dosage_and_administration_table":["<table width=\"551.2px\" cellspacing=\"0\" cellpadding=\"0\"><col width=\"1px\"/><col width=\"1px\"/><tbody><tr><td styleCode=\" Botrule Rrule\"><content styleCode=\"bold\"> Age (yr)</content></td><td styleCode=\" Botrule Lrule\"><content styleCode=\"bold\">Dose (chewable tablets)</content></td></tr><tr><td styleCode=\" Botrule Rrule\">children under 2 years  </td><td styleCode=\" Botrule Lrule\">do not use</td></tr><tr><td styleCode=\" Botrule Toprule Rrule\">children 2 to 5 years  </td><td styleCode=\" Botrule Toprule Lrule\">do not use unless directed by a doctor</td></tr><tr><td styleCode=\" Botrule Toprule Rrule\">children 6 to 11 years</td><td styleCode=\" Botrule Toprule Lrule\">1 to 2 chewable tablets (12.5 mg to 25 mg)</td></tr><tr><td styleCode=\" Toprule Rrule\">adults and children 12 years and over  </td><td styleCode=\" Toprule Lrule\">2 to 4 chewable tablets (25 mg to 50 mg)</td></tr></tbody></table>"],"effective_time":"20260708","id":"63271716-2607-4cd3-9165-6b4dfab4c079","inactive_ingredient":["Inactive ingredients D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose"],"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":{"application_number":["M012"],"brand_name":["Childrens Allergy Relief"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates, LLC"],"package_ndc":["36800-585-44"],"product_ndc":["36800-585"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049900"],"spl_id":["63271716-2607-4cd3-9165-6b4dfab4c079"],"spl_set_id":["bfcabe02-7961-4407-a748-8cd087731398"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0036800414358"]},"package_label_principal_display_panel":["Principal Display Panel +TopCare ® health NDC 36800-585-44 COMPARE TO CHILDREN'S BENADRYL® CHEWABLES ACTIVE INGREDIENT* children's Allergy Relief DIPHENHYDRAMINE HCl 12.5 mg CHEWABLE TABLETS - ANTIHISTAMINE 4-6 HOURS/ DOSE RELIEF OF: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Nose or Throat 18 CHEWABLE TABLETS Chew or crush tablets completely before swallowing. For Ages 6 to 11 Years GRAPE FLAVOR actual size Topcare 44-585 Topcare 44-585"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-888-423-0139"],"set_id":"bfcabe02-7961-4407-a748-8cd087731398","spl_product_data_elements":["Childrens Allergy Relief Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 27 ALUMINUM LAKE D&C RED NO. 30 ALUMINUM LAKE DEXTROSE MONOHYDRATE ETHYLCELLULOSE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE MANNITOL STEARIC ACID SUCRALOSE SUCROSE 44;585"],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number"],"version":"12","warnings":["Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages marked drowsiness may occur excitability may occur, especially in children 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 alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages marked drowsiness may occur excitability may occur, especially in children"]}