{ "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": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "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" ], "active_ingredient": [ "Active ingredient (in each tablet) Diphenhydramine HCl 12.5 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 ▪ 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" ], "do_not_use": [ "Do not use ▪ to make a child sleepy ▪ with any other product containing diphenhydramine, even one used on skin" ], "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." ], "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" ], "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 right away at 1-800-222-1222" ], "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": [ "
Age (Yr)Dose (chewable tablets)
children under 2 years of agedo not use
children 2 to under 5 years of agedo 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
" ], "storage_and_handling": [ "Other information ▪ store below at room temperature. Avoid high humidity. Protect from light." ], "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" ], "questions": [ "Questions or comments ? 1-866-467-2748" ], "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" ], "set_id": "dd2be906-bd0a-437c-9693-54b9391a5da3", "id": "27297b57-3765-4bb9-ba60-df495d64bea0", "effective_time": "20260905", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Drx Choice childrens allergy chews" ], "generic_name": [ "DIPHENHYDRAMINE HCL" ], "manufacturer_name": [ "RARITAN PHARMACEUTICALS INC" ], "product_ndc": [ "68163-012" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1049900" ], "spl_id": [ "27297b57-3765-4bb9-ba60-df495d64bea0" ], "spl_set_id": [ "dd2be906-bd0a-437c-9693-54b9391a5da3" ], "package_ndc": [ "68163-012-48" ], "is_original_packager": [ true ], "unii": [ "TC2D6JAD40" ] } } ] }