{"active_ingredient":["Active ingredient (in each chewable tablet) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 find right dose on chart below 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":["
Age (yr)Dose (chewable tablets)
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to 11 years1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)
"],"effective_time":"20241108","id":"215db1b4-b8fb-90be-e063-6294a90a6353","inactive_ingredient":["Inactive ingredients crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7 calcium lake, dextrose excipient, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, sucralose, sugar spheres, tartaric acid"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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. (1-800-222-1222)"],"openfda":{"application_number":["M012"],"brand_name":["Childrens Benadryl Chewables"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-232-01"],"product_ndc":["50580-232"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049900","1049901"],"spl_id":["215db1b4-b8fb-90be-e063-6294a90a6353"],"spl_set_id":["b08f71d8-a06c-41ba-8ed1-fbc41dbc1919"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0300450553201"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-232-01 Children's Benadryl ® ALLERGY Diphenhydramine HCl/antihistamine 12.5 mg chewable tablets Chewables 4-6 Hours/Dose RELIEF OF: Runny Nose Sneezing Itchy, Watery Eyes Itchy Throat or Nose 20 Chewable Tablets Grape! Flavored Tablets Actual Size PRINCIPAL DISPLAY PANEL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a healthcare professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? call 1-877-717-2824 or 215-273-8755 (collect)"],"set_id":"b08f71d8-a06c-41ba-8ed1-fbc41dbc1919","spl_product_data_elements":["Childrens Benadryl Chewables diphenhydramine hydrochloride ALUMINUM OXIDE D&C RED NO. 7 DEXTROSE, UNSPECIFIED FORM ETHYLCELLULOSES FD&C BLUE NO. 1 ACACIA HYDROXYPROPYL CELLULOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE SUCRALOSE TARTARIC ACID DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSPOVIDONE D&C RED NO. 30 MAGNESIUM STEARATE B"],"spl_unclassified_section":["Drug Facts"],"storage_and_handling":["Other information store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if carton or blister unit is opened or broken/unsealed see bottom panel for lot number and expiration date"],"version":"7","warnings":["Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma 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 alcohol 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 healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"when_using":["When using this product marked drowsiness may occur avoid alcohol drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}