{"active_ingredient":["Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg"],"ask_doctor":["Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers."],"do_not_use":["Do not use with any other drug containing diphenhydramine, even one used on skin to make a child sleepy"],"dosage_and_administration":["Directions do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product find the right dose on chart below Age (yr) Dose (mL) children 6 to 11 years 5mL to 10 mL children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use"],"dosage_and_administration_table":["
Age (yr) Dose (mL)
children 6 to 11 years5mL to 10 mL
children 2 to 5 years do not use unless directed by a doctor
children under 2 yearsdo not use
"],"effective_time":"20240415","id":"cb18f7c6-b7e5-4609-93f6-8fe61b41ba6e","inactive_ingredient":["Inactive ingredients anhydrous citric acid,carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose 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 (1-800-222-1222) right away."],"openfda":{"application_number":["M012"],"brand_name":["Childrens Dye Free Allergy"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["P & L Development, LLC"],"package_ndc":["49580-0293-4"],"product_ndc":["49580-0293"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049906"],"spl_id":["cb18f7c6-b7e5-4609-93f6-8fe61b41ba6e"],"spl_set_id":["1c4d09ed-4e0f-430d-b17f-6a23f996a55d"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["Principal Display Panel Compare to active ingredient in Children's Benadryl® Allergy* Children's dye-free​​ allergy Diphenhydramine HCl 12.5 mg Antihistamine relieves: sneezing runny nose itchy, watery eyes itching of the nose or throat For Ages 6 to 11 alcohol free dye-free bubblegum Flavor FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING . Manufactured by: PL Developments 11865 S. Alameda St Lynwood, CA 90262","Package Label Readyincase Children's Dye-Free Allergy Diphenhydramine HCI 12.5 mg"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM ES T"],"set_id":"1c4d09ed-4e0f-430d-b17f-6a23f996a55d","spl_product_data_elements":["Childrens Dye Free Allergy Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID GLYCERIN WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE CARBOXYMETHYLCELLULOSE SODIUM SACCHARIN SODIUM SORBITOL"],"storage_and_handling":["Other information each 5 mL contains: sodium 8 mg store between 20°-25°C (68°-77°F). Do not refrigerate. protect from light. Store in outer carton until contents are used"],"version":"6","warnings":["Warnings Do not use with any other drug containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children"]}