{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask your doctor before use if you have ▪ glaucoma ▪ a breathing problem such as emphysema or chronic bronchitis ▪ trouble urinating due to an enlarged 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 ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["Directions ▪ chew one tablet completely at the onset of symptoms. Do not swallow tablets whole. ▪ Find right dose on chart below ▪ take every 4 to 6 hours, or as directed by a doctor ▪ do not take more than 6 doses in 24 hours Age (Yr) Dose (chewable tablets) children under 2 years of age do not use children 2 to under 5 years of age do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 tablets adults and children 12 years of age and over 2 to 4 tablets"],"dosage_and_administration_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"50%\"/><col width=\"44%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Age (Yr)</content></paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Dose (chewable tablets)</content></paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children under 2 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>do not use </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 2 to under 5 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>do not use unless directed by a doctor </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 6 to under 12 years of age </paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>1 to 2 tablets </paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years of age and over </paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>2 to 4 tablets</paragraph></td></tr></tbody></table>"],"effective_time":"20260905","id":"27297b57-3765-4bb9-ba60-df495d64bea0","inactive_ingredient":["Inactive ingredients citric acid, crospovidone, D&C Red No.30, dextrose, FD&C Blue No 1, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, 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 at 1-800-222-1222"],"openfda":{"application_number":["M012"],"brand_name":["Drx Choice childrens allergy chews"],"generic_name":["DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS INC"],"package_ndc":["68163-012-48"],"product_ndc":["68163-012"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049900"],"spl_id":["27297b57-3765-4bb9-ba60-df495d64bea0"],"spl_set_id":["dd2be906-bd0a-437c-9693-54b9391a5da3"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Principal Display Panel NDC 68163-012-48 Compare to active ingredient in Children's Benadryl® Allergy Chewable Tablets DRx Choice children's allergy chews diphenhydramine HCl, 12.5 mg/ antihistamine For Relief of: • Sneezing • Runny nose • Itchy throat or Nose • Itchy, watery eyes 48 Chewable Tablets Grape Flavor 4-6 HOURS/DOSE TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Consumer INC, owner of the registered trademark Children's Benadryl® Allergy Chewable Tablets. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 IMPORTANT: Keep this carton for future reference on full labelling DRx Choice Children's allergy Chews 48 Tablets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments ? 1-866-467-2748"],"set_id":"dd2be906-bd0a-437c-9693-54b9391a5da3","spl_product_data_elements":["Drx Choice childrens allergy chews Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (120 .MU.M) D&C RED NO. 30 DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 MAGNESIUM STEARATE MALTODEXTRIN POTASSIUM CITRATE SILICON DIOXIDE SODIUM POLYSTYRENE SULFONATE STARCH, CORN SUCRALOSE RP012"],"storage_and_handling":["Other information ▪ store below at room temperature. Avoid high humidity. Protect from light."],"version":"5","warnings":["Warnings Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin Ask your doctor before use if you have ▪ glaucoma ▪ a breathing problem such as emphysema or chronic bronchitis ▪ trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product ▪ marked drowsiness may occur ▪ avoid alcoholic drinks ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ 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 at 1-800-222-1222"],"when_using":["When using this product ▪ marked drowsiness may occur ▪ avoid alcoholic drinks ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children"]}