{"active_ingredient":["ACTIVE INGREDIENT (in each soft chew) Diphenhydramine HCl 12.5mg"],"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 child sleepy With any other product containing diphenhydramine, even one used on skin"],"dosage_and_administration":["DIRECTIONS Adults and children 12 years and over: Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor Do not take more than 6 times in 24 hours Chew each soft chew thoroughly before swallowing Children 6 to 11 years: Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor. Do not take more than 6 times in 24 hours Chew each soft chew thoroughly before swallowing Children under 6 years: Do not use"],"effective_time":"20241127","how_supplied":["HOW SUPPLIED Diphenhydramine 12.5mg Soft Chews is supplied in the following dosage form: Twenty (20) Soft Chews per container ***Made in USA*** Manufactured for: Alexso, Inc. 2317 Cotner Ave Los Angeles, CA 90064 NDC: 50488-4125-1 Size: 20 Soft Chews"],"id":"801d50c1-d2ef-4c14-8843-9be29507aa26","inactive_ingredient":["Inactive ingredients: citric acid, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate."],"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 (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Diphenhydramine HCl 12.5 mg Soft Chews 20 Bubble Gum Flavored Gummies Chewy Gummy Bites NDC: 50488-4125-1 Patent Pending Diphenhydramine HCl 12.5 mg Soft Chews 20 Bubble Gum Flavored Gummies Chewy Gummy Bites NDC:50488-4125-1 Patent Pending"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Antihistamine"],"questions":["Questions or comments? Call 888-495-6078"],"set_id":"41b6e96a-9fce-4aa2-9eeb-3a5bd5f7af41","spl_product_data_elements":["Diphenhydramine HCl 12.5mg Antihistamine Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE ANHYDROUS DEXTROSE HYDROXYPROPYL BETADEX MAGNESIUM STEARATE MALTITOL MALTODEXTRIN MINERAL OIL NEOTAME WATER CARRAGEENAN SODIUM CHLORIDE STARCH, CORN CORN SYRUP SUCRALOSE SUCROSE TRISODIUM CITRATE DIHYDRATE Light yellow to golden brown"],"spl_unclassified_section":["Diphenhydramine HCl 12.5 mg Soft Chews Alexso, Inc. ---------------- Diphenhydramine HCl 12.5 mg Soft Chews DRUG FACTS"],"storage_and_handling":["OTHER INFORMATION each soft chew contains: sodium 7 mg . Very low sodium. store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing."],"version":"3","warnings":["WARNINGS Do not use To make 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 Excitability may occur, especially in children Marked drowsiness may occur Avoid alcoholic drinks Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery 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 (1-800-222-1222) right away."],"when_using":["When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid alcoholic drinks Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery"]}