{"active_ingredient":["Active ingredient (in each tablet) Diphenhydramine 25 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 ▪ Use as directed per healthcare professional. ▪ take every 4 to 6 hours, or as directed by a doctor ▪ do not take more than 6 doses in 24 hours adults and children 12 years and older 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use"],"dosage_and_administration_table":["
adults and children 12 years and older1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use
"],"effective_time":"20260807","id":"887cabe5-46d0-4f4e-8f5a-2cfdbc157b58","inactive_ingredient":["Inactive ingredients carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide"],"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 nose ▪ temporarily relieves these symptoms due to the common cold: ▪ runny nose ▪ sneezing"],"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":["Diphenhydramine Hydrochloride"],"generic_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"manufacturer_name":["Cardinal Health 107, LLC"],"original_packager_product_ndc":["68094-018"],"package_ndc":["55154-1589-0"],"product_ndc":["55154-1589"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["887cabe5-46d0-4f4e-8f5a-2cfdbc157b58"],"spl_set_id":["887cabe5-46d0-4f4e-8f5a-2cfdbc157b58"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"],"upc":["0055154158909"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-1589-0 DiphenhydrAMINE HCl TABLETS 25 mg 10 TABLETS 25mg bag label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-397-9228"],"set_id":"887cabe5-46d0-4f4e-8f5a-2cfdbc157b58","spl_product_data_elements":["Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSPOVIDONE (120 .MU.M) D&C RED NO. 27 ALUMINUM LAKE DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE dark L479;25"],"spl_unclassified_section":["25 mg Tablets For Hospital Use Only LI1729 Rev. 10/24 Drug Facts","Gluten Free","How Supplied They are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-1589-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.","Packaged by: Precision Dose, Inc. South Beloit, IL 61080 Distributed By: Cardinal Health Dublin, OH 43017 L61501480726 For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com LI1729 Rev. 10/24"],"storage_and_handling":["Other information ▪ each tablet contains: calcium 20 mg ▪ store at 20-25°C (68-77°F). ▪ Avoid high humidity. Protect from light ▪ small tablet size, easy to swallow"],"version":"1","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 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 (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"]}