{"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":"20250912","how_supplied":["How Supplied They are supplied as follows: NDC 68094-018-61 Unit Dose Packages of 100 Tablets (10×10) per Carton"],"id":"315b150d-b34d-422c-b3c4-287dd908df8f","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":["Precision Dose, Inc."],"original_packager_product_ndc":["0113-0479"],"package_ndc":["68094-018-59","68094-018-61"],"product_ndc":["68094-018"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1049630"],"spl_id":["315b150d-b34d-422c-b3c4-287dd908df8f"],"spl_set_id":["4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["TC2D6JAD40"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label PrecisionDose™ NDC 68094-018-61 Unit Dose diphenhydrAMINE HCl 25 mg Tablets 100 Tablets (10x10) Each tablet contains: Diphenhydramine Hydrochloride 25 mg Calcium 20 mg Gluten Free USUAL DOSE: SEE ENCLOSED DRUG FACTS. Store at 20-25°C (68-77°F). Avoid high humidity. Protect from light. Keep out of reach of children. Hospital Use Only. LC1733 R0 Packaged by: Precision Dose, Inc. South Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton 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":"4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4","spl_product_data_elements":["Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride diphenhydramine hydrochloride diphenhydramine carnauba wax crospovidone (120 .MU.M) D&C Red No. 27 HYPROMELLOSE, UNSPECIFIED Magnesium Stearate MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED Polysorbate 80 STEARIC ACID Titanium dioxide anhydrous dibasic calcium phosphate dark L479;25"],"spl_unclassified_section":["25 mg Tablets For Hospital Use Only LI1729 Rev. 10/24 Drug Facts","Gluten Free","Packaged by: Precision Dose, Inc. South Beloit, IL 61080 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":"5","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"]}